CClinicalTrials.gg
RecruitingNCT07645534Updated Jun 12, 2026

Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.

A Phase 1 interventional study of Ingavirin forte, capsules, 90 mg + 20 mg and Ingavirin, capsules, 90 mg in Influenza and Acute Respiratory Viral Infections, sponsored by Valenta Pharm JSC. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Valenta Pharm JSC · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2025, registered May 2026).
  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions.

02

Conditions studied

  • Influenza
  • Acute Respiratory Viral Infections

Browse trials for

03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 36 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
  2. Males and females aged 18 to 45 years (inclusive);
  3. Confirmed healthy status, defined as the absence of clinically significant abnormalities based on clinical evaluation, laboratory assessments, and diagnostic procedures as specified in the protocol;
  4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);
  5. Heart rate (HR) from 60 to 89 beats/min (inclusive);
  6. Respiratory rate (RR) from 12 to 20 per minute (inclusive);
  7. Body temperature from 36.0°C to 36.9°C (inclusive);
  8. Body mass index (BMI) of 18.5 kg/m² ≤ BMI ≤ 30 kg/m², with body weight for men being ≥ 55 kg and for women ≥ 45 kg;
  9. Agreement to use adequate methods of contraception throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine β-hCG test result;
  10. Subjects must demonstrate appropriate behavior and coherent speech;
  11. Ability to comply with the daily routine and diet prescribed by the study protocol.

Noninclusion Criteria:

  1. Clinically significant allergic history;
  2. History of hypersensitivity to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
  3. History of drug intolerance to imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or to the excipients contained in the investigational medicinal product;
  4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
  5. Chronic diseases of the kidneys, liver, gastrointestinal (GI) tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary, or immune systems, or of the skin, hematopoietic organs, or eyes;
  6. History of gastrointestinal (GI) surgical procedures, with the exception of appendectomy performed at least 1 year prior to screening;
  7. Diseases/conditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the investigational medicinal product (IMP);
  8. Acute infectious diseases less than 4 weeks prior to screening;
  9. Use of medicinal products (MPs) that have a pronounced effect on hemodynamics, MPs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), MPs prolonging the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)) less than 2 months prior to screening;
  10. Regular use of MPs less than 2 weeks prior to screening and single use of MPs less than 7 days prior to screening (including over-the-counter MPs, vitamins, dietary supplements, herbal medicinal products);
  11. Donation of blood or plasma less than 3 months prior to screening;
  12. Use of hormonal contraceptives by womeninitiated less than 2 months prior to the screening visit.
  13. Use of depot injections of any MPs less than 3 months prior to the start of screening;
  14. Pregnancy or breastfeeding; positive urine pregnancy test result for women of childbearing potential;
  15. Women of childbearing potential with a history of unprotected sexual intercourse within 30 days prior to study drug administration with a non-sterilized partner;
  16. Participation in another clinical trial within 3 months prior to screening or concurrently with the current study.
  17. Consumption of more than 10 standard alcohol units per week during the month prior to study enrollment, (1 standard unit = 500 mL beer, 200 mL wine, or 50 mL of strong alcoholic beverages), or history of alcoholism, drug dependence, or substance abuse.
  18. Currently smoking more than 10 cigarettes per day, or a history of smoking the specified number of cigarettes within the 6 months preceding screening; refusal to abstain from smoking while staying at the study center;
  19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to IMP administration;
  20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or St. John's wort-containing preparations or products within 7 days prior to IMP administration;
  21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to IMP administration;
  22. Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus antigens at screening;
  23. Clinically significant abnormalities on the electrocardiogram (ECG) in the medical history and/or at screening, including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women;
  24. History of risk factors for torsades de pointes, such as heart failure, hypokalemia, or family history of long QT syndrome;
  25. Electrolyte imbalances (based on Na+, K+, Cl- levels at screening);
  26. Positive urine test for narcotic substances and potent medicinal products at screening;
  27. Positive breath alcohol test at screening;
  28. Planned hospitalization during the study period for any reason other than hospitalization required by this protocol;
  29. Inability or incapacity to comply with the protocol requirements, perform protocol-specified procedures, or adhere to the diet and activity restrictions;
  30. Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical, and dental educational institutions; subordinate clinical or laboratory staff; employees of pharmaceutical companies; military personnel and prisoners; residents of long-term care facilities; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or trusteeship; persons incapable of providing informed consent; as well as law enforcement officers;
  31. Any other condition which, in the Investigator's judgment, would preclude the subject's enrollment in the study or could lead to premature withdrawal, including adherence to fasting practices or special diets (e.g., vegetarian, vegan, sodium-restricted) or lifestyle factors (e.g., night shift work, extreme physical exertion).

Exclusion criteria

Exclusion criteria:

  1. Subject's decision to discontinue participation in the study;
  2. Subject non-compliance with protocol requirements, including but not limited to missed study procedures, unauthorized use of prohibited concomitant medications, or failure to adhere to protocol-defined dietary and lifestyle restrictions.
  3. Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);
  4. Subjects enrolled in the study despite not meeting eligibility criteria (inclusion/exclusion criteria violations).
  5. Prolongation of the QTcF interval on ECG recording (>500 ms or >60 ms compared to baseline measured on Days 1, 8, 15, and 22);
  6. Occurrence of a severe adverse event (AE) and/or serious adverse event (SAE) during study participation
  7. Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;
  8. The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;
  9. Occurrence of vomiting/diarrhea within 8 hours after administration of the study drug;
  10. Positive urine test for narcotic substances and potent medicinal products;
  11. Positive breath alcohol test;
  12. Positive urine β-hCG test result in women;
  13. Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    ACBD sequence

    ACBD sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions.

    Drug: Ingavirin forte, capsules, 90 mg + 20 mg · Drug: Ingavirin, capsules, 90 mg

  • Experimental
    BADC sequence

    BADC sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions.

    Drug: Ingavirin forte, capsules, 90 mg + 20 mg · Drug: Ingavirin, capsules, 90 mg

  • Experimental
    CDAB sequence

    CDAB sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions.

    Drug: Ingavirin forte, capsules, 90 mg + 20 mg · Drug: Ingavirin, capsules, 90 mg

  • Experimental
    DBCA sequence

    DBCA sequence, where: A - Ingavirin forte under fasting conditions; B - Ingavirin forte under fed conditions; C - Ingavirin under fasting conditions; D - Ingavirin under fed conditions.

    Drug: Ingavirin forte, capsules, 90 mg + 20 mg · Drug: Ingavirin, capsules, 90 mg

Interventions

  • DrugIngavirin forte, capsules, 90 mg + 20 mg

    Ingavirin forte containing 90 mg of imidazolylethanamide of pentanedioic acid and 20 mg of N,N'-bis-\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\] diamide of malonic acid (XC9)

    Also known as: imidazolylethanamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9)

  • DrugIngavirin, capsules, 90 mg

    Ingavirin containing 90 mg of imidazolylethanamide of pentanedioic acid

    Also known as: imidazolylethanamide of pentanedioic acid

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - Cmax

    Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below.

    Time frame: From 0 to 24 hours

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax)

    Time frame: From 0 to 24 hours

  3. Pharmacokinetics - AUC0-t

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

    Time frame: From 0 to 24 hours

  4. Pharmacokinetics - AUC0-inf

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Time frame: From 0 to 24 hours

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Time frame: From 0 to 24 hours

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2)

    Time frame: From 0 to 24 hours

  7. Pharmacokinetics - kel

    Elimination constant (kel)

    Time frame: From 0 to 24 hours

  8. Pharmacokinetics - number of terminal timepoints

    Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant

    Time frame: From 0 to 24 hours

Secondary outcomes

  1. Adverse event type

    Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.

    Time frame: From Screening to Day 29 ± 1

  2. Adverse event number

    Number of adverse events registered during the study

    Time frame: From Screening to Day 29 ± 1

  3. Adverse event severety

    Severity of adverse events registered during the study, assessed using the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: From Screening to Day 29 ± 1

  4. Discontinuations due to adverse events related to the investigational product

    Number of subjects who discontinued the study early due to adverse events (including serious adverse events) related to the investigational product

    Time frame: From Screening to Day 29 ± 1

  5. Safety and Tolerability: volunteer complaints

    Description of any health-related complaints received from volunteer

    Time frame: From Screening to Day 29 ± 1

  6. Safety and Tolerability: physical examination results - cardiovascular system

    An assessment of the condition of the cardiovascular system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/cardiovascular symptoms, if any)

    Time frame: From Screening to Day 23

  7. Safety and Tolerability: physical examination results - respiratory system

    An assessment of the condition of the respiratory system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/respiratory symptoms, if any)

    Time frame: From Screening to Day 23

  8. Safety and Tolerability: physical examination results - digestive tract

    An assessment of the condition of the digestive tract and associated symptoms on physical examination (normal condition or a description of abnormal conditions/digestive tract symptoms, if any)

    Time frame: From Screening to Day 23

  9. Safety and Tolerability: physical examination results - endocrine system

    An assessment of the condition of the endocrine system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/endocrine symptoms, if any)

    Time frame: From Screening to Day 23

  10. Safety and Tolerability: physical examination results - musculoskeletal system

    An assessment of the condition of the musculoskeletal system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/musculoskeletal symptoms, if any)

    Time frame: From Screening to Day 23

  11. Safety and Tolerability: physical examination results - nervous system

    An assessment of the condition of the nervous system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/neurological symptoms, if any)

    Time frame: From Screening to Day 23

  12. Safety and Tolerability: physical examination results - sensory systems

    An assessment of the condition of the sensory systems and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any)

    Time frame: From Screening to Day 23

  13. Safety and Tolerability: physical examination results - skin/visible mucous membranes

    An assessment of the condition of the skin/visible mucous membranes and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any)

    Time frame: From Screening to Day 23

  14. Safety and Tolerability: vital signs - systolic blood pressure

    Systolic blood pressure (SBP, mmHg)

    Time frame: From Screening to Day 23

  15. Safety and Tolerability: vital signs - diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg)

    Time frame: From Screening to Day 23

  16. Safety and Tolerability: vital signs - heart rate

    Heart rate (HR, bpm)

    Time frame: From Screening to Day 23

  17. Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)

    Body temperature (Celsius temperature scale)

    Time frame: From Screening to Day 23

  18. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)

    Time frame: From Screening to Day 23

  19. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)

    Time frame: From Screening to Day 23

  20. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)

    Time frame: From Screening to Day 23

  21. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave; Fredericia correction)

    Time frame: From Screening to Day 23

  22. Safety and Tolerability: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Time frame: From Screening to Day 23

  23. Safety and Tolerability: clinical blood test - hematocrit

    Hematocrit (%)

    Time frame: From Screening to Day 23

  24. Safety and Tolerability: clinical blood test - red blood cell count

    Red blood cell count (cells/L)

    Time frame: From Screening to Day 23

  25. Safety and Tolerability: clinical blood test - platelet count

    Platelet count (cells/L)

    Time frame: From Screening to Day 23

  26. Safety and Tolerability: clinical blood test - leukocyte count

    Leukocyte count (cells/L)

    Time frame: From Screening to Day 23

  27. Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate (mm/h)

    Time frame: From Screening to Day 23

  28. Safety and Tolerability: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Time frame: From Screening to Day 23

  29. Safety and Tolerability: clinical blood test - band neutrophils

    Leukocyte formula (band neutrophils, %)

    Time frame: From Screening to Day 23

  30. Safety and Tolerability: clinical blood test - segmented neutrophils

    Leukocyte formula (segmented neutrophils, %)

    Time frame: From Screening to Day 23

  31. Safety and Tolerability: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Time frame: From Screening to Day 23

  32. Safety and Tolerability: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Time frame: From Screening to Day 23

  33. Safety and Tolerability: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Time frame: From Screening to Day 23

  34. Safety and Tolerability: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Time frame: From Screening to Day 23

  35. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Time frame: From Screening to Day 23

  36. Safety and Tolerability: urinalysis - color

    Color of the urine

    Time frame: From Screening to Day 23

  37. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Time frame: From Screening to Day 23

  38. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Time frame: From Screening to Day 23

  39. Safety and Tolerability: urinalysis - protein

    Protein concentration (g/L)

    Time frame: From Screening to Day 23

  40. Safety and Tolerability: urinalysis - glucose

    Glucose concentration (mmol/L)

    Time frame: From Screening to Day 23

  41. Safety and Tolerability: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Time frame: From Screening to Day 23

  42. Safety and Tolerability: urinalysis - white blood cells

    White blood cell content (number in sight)

    Time frame: From Screening to Day 23

  43. Safety and Tolerability: urinalysis - epithelial cells

    Epithelial cell content (number in sight)

    Time frame: From Screening to Day 23

  44. Safety and Tolerability: urinalysis - casts

    Presence of casts (Yes/No)

    Time frame: From Screening to Day 23

  45. Safety and Tolerability: urinalysis - mucus

    Presence of mucus (Yes/No)

    Time frame: From Screening to Day 23

  46. Safety and Tolerability: urinalysis - bacteria

    Presence of bacteria (Yes/No)

    Time frame: From Screening to Day 23

  47. Safety and Tolerability: urinalysis (microscopy)

    Changes in urine sediment parameters (RBCs, WBCs, casts, crystals) as assessed by microscopy

    Time frame: From Screening to Day 23

  48. Safety and Tolerability: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Time frame: From Screening to Day 23

  49. Safety and Tolerability: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Time frame: From Screening to Day 23

  50. Safety and Tolerability: blood chemistry - protein

    Total protein concentration (g/L)

    Time frame: From Screening to Day 23

  51. Safety and Tolerability: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Time frame: From Screening to Day 23

  52. Safety and Tolerability: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Time frame: From Screening to Day 23

  53. Safety and Tolerability: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Time frame: From Screening to Day 23

  54. Safety and Tolerability: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Time frame: From Screening to Day 23

  55. Safety and Tolerability: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Time frame: From Screening to Day 23

  56. Safety and Tolerability: blood chemistry - potassium concentration

    Potassium (mmol/L)

    Time frame: From Screening to Day 23

  57. Safety and Tolerability: blood chemistry - sodium concentration

    Sodium concentration (mmol/L)

    Time frame: From Screening to Day 23

  58. Safety and Tolerability: blood chemistry - chloride concentration

    Chloride concentration (mmol/L)

    Time frame: From Screening to Day 23

  59. Safety and Tolerability: blood chemistry - GFR

    Glomerular filtration rate, GFR (mL/min/1,73 м²)

    Time frame: From Screening to Day 23

07

Study locations

1 of 1 sites recruiting
  • Federal Budgetary Institution of Science "North-West Public Health Research Center"
    Saint Petersburg, 191036, Russia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07645534
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Jul 11, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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