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CompletedNCT05412173Updated Jul 27, 2023

Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers

An interventional study of Molnupiravir in Viral Infection and COVID-19, sponsored by Valenta Pharm JSC. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Valenta Pharm JSC · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The study aimed for:

  1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs);
  2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.
02

Conditions studied

  • Viral Infection
  • COVID-19

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03

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

This study's enrollment of 37 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.

Browse Virus Diseases 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. Presence of written consent of the volunteer to participate in the study in accordance with applicable law.
  2. Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive).
  3. Verified diagnosis "healthy": no deviations from the reference values of the data of standard clinical, laboratory and instrumental methods of examination.
  4. Systolic blood pressure (SBP) in the range of 110-130 mmHg; diastolic blood pressure (DBP) is 60-85 mmHg).
  5. 60-90 bpm at rest for heart rate (HR).
  6. 16-20 breaths/min for respiratory rate (RR).
  7. 35.5 to 36.9°C for body temperature.
  8. Body mass index (BMI) within the range of 18.5 ≤ BMI ≤ 30 kg/m2 with a body weight not less than 45 kg for female and not less than 55 kg for male volunteers.
  9. The consent of the volunteer (including the partner) to use adequate methods of contraception during the study and 30 days after its completion; for female volunteers - negative blood/urine test result for β-chorionic gonadotropin.
  10. Volunteers must behave adequately, coherent speech must be observed.

Exclusion criteria

Exclusion Criteria:

  1. A history of allergy;
  2. A history of drug intolerance to the active and/or excipients in the study drugs;
  3. Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, blood and vision;
  4. History of gastrointestinal surgery (except appendectomy at least 1 year prior to screening);
  5. Diseases/conditions that in the opinion of the investigator may affect the absorption, distribution, metabolism or excretion of the study drugs (drugs);
  6. Acute infectious disease less than 4 weeks prior to screening;
  7. Taking medications that significantly affect hemodynamics and medications that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months prior to screening;
  8. Regularly taking a medicines less than 2 weeks before screening and taking a single medicine less than 7 days before screening;
  9. Donating blood or plasma less than 3 months before screening;
  10. Use of hormonal contraceptives (in women) less than 2 months before screening;
  11. The use of depot injections of any drug less than 3 months before screening;
  12. Pregnancy or lactation; positive blood/urine β-CGH test for women with preserved reproductive potential;
  13. Women of preserved reproductive potential with a history of unprotected intercourse within 30 days prior to study drug administration with an unsterilized partner;
  14. Participation in another clinical trial less than 3 months prior to screening or concurrently with the present study;
  15. Taking more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 mL of beer, 150 mL of wine or 40 mL of spirits) in the week in the last month before inclusion in the study or anamnestic evidence of alcoholism, drug addiction, drug abuse;
  16. Smoking more than 10 cigarettes per day currently, or a history of smoking the specified number of cigarettes during the 6 months prior to screening; disagreement to abstain from smoking for the duration of the hospital stay;
  17. Positive blood tests for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens, rapid tests of biomaterial (nasopharyngeal and/or oropharyngeal swab) for Severe Acute Respiratory Syndrome Coronavirus 2 antigen (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19);
  18. Clinically significant abnormalities on the electrocardiogram (ECG);
  19. Positive urinalysis for narcotics and potent drugs;
  20. Positive test for the content of alcohol vapor in exhaled air.
  21. Scheduling an inpatient stay during the study period, for any reason other than hospitalization required by this protocol.
  22. Inability to meet the requirements of the protocol, perform the procedures prescribed in the protocol, follow the diet, activity regimen.
  23. Other conditions that, in the opinion of the Investigator, preclude inclusion of the volunteer in the study or may result in early withdrawal of the volunteer from the study, including fasting or a special diet (e.g. vegetarian, vegan, limited table salt) or a special lifestyle (night work, extreme physical activity).

Withdrawal criteria:

  1. A volunteer withdraws from further participation in the study;
  2. Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
  3. Occurrence of causes/occurrence during the study of situations that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
  4. Volunteers selected for the study in violation of the inclusion/inclusion criteria;
  5. Volunteer's development of severe adverse event during the study;
  6. Missing 2 or more consecutive blood samples or 3 or more blood samples during the same Study Period.
  7. Occurrence of vomiting/diarrhea within 6 hours of study drug administration;
  8. Positive urine test for narcotics and drugs;
  9. Positive breath alcohol vapor test.
  10. Positive pregnancy test in women;
  11. Positive test for COVID-19;
  12. The occurrence in the course of the study of other reasons that prevent the study according to the protocol.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Other
    RT-sequence

    The volunteers will take 1 capsule (200 mg) of Lagevrio (R), 200 mg capsules (Merck Sharp \& Dohme (UK) Limited, UK) in Period 1, and 1 capsule (200 mg) of Molnupiravir (T), 200 mg capsules (Valenta Pharm, Russia) in Period 2.

    Drug: Molnupiravir

  • Other
    TR-sequence

    The volunteers will take 1 capsule (200 mg) of the drug Molnupiravir (T), capsules, 200 mg (Valenta Pharm JSC, Russia) in Period 1, and 1 capsule (200 mg) of the drug Lagevrio (R), capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK) in Period 2.

    Drug: Molnupiravir

Interventions

  • DrugMolnupiravir

    A single dose of R or T drug in each of 2 periods of the study in fasted conditions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - Cmax

    Maximum plasma concentration (Cmax) of β-D-N-4-hydroxycytidine (NHC)

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax) of NHC

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  3. Pharmacokinetics - AUC0-t

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

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  4. Pharmacokinetics - AUC0-inf

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

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC of NHC, defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2) of NHC

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  7. Pharmacokinetics - kel

    Elimination constant (kel) of NHC

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  8. Pharmacokinetics - MRT

    Mean residence time (MRT) of NHC

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  9. Bioequivalence - ratio of Cmax

    Ratio of geometric mean Cmax for NHC after intake of R or T (with 90% confidence intervals)

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  10. Bioequivalence - ratio of AUC0-t

    Ratio of geometric mean AUC0-t for NHC after intake of R or T (with 90% confidence intervals)

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

  11. Bioequivalence - ratio of AUC0-inf

    Ratio of geometric mean AUC0-inf for NHC after intake of R or T (with 90% confidence intervals)

    Time frame: From 0 to 24 hours (Day 1-2 and Day 8-9)

Secondary outcomes

  1. Safety and Tolerability: adverse event (AE) number and frequency

    Number and frequency of adverse events (AEs) or serious AEs (SAEs)

    Time frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)

  2. Safety and Tolerability: adverse event (AE) characteristics

    Description and severity of AEs or serious AEs (SAEs), concomitant therapy for AEs/SAEs, causal relationship, outcomes.

    Time frame: From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14)

  3. Safety and Tolerability: vital signs - systolic blood pressure (SBP)

    SBP, mmHg

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  4. Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

    DBP, mmHg

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  5. Safety and Tolerability: vital signs - respiratory rate (RR)

    RR, breaths per minute

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  6. Safety and Tolerability: vital signs - heart rate (HR)

    HR, beats per minute

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  7. Safety and Tolerability: vital signs - body temperature

    Body temperature, centigrade scale

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  8. Safety and Tolerability: physical examination results

    Physical examination results

    Time frame: Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  9. Safety and Tolerability: urinalysis - color

    Color of the urine

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  10. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  11. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  12. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  13. Safety and Tolerability: urinalysis - nitrites

    Nitrites in the urine (+/-)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  14. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  15. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  16. Safety and Tolerability: urinalysis - ketones

    Ketones in the urine (mmol/L)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  17. Safety and Tolerability: urinalysis - urobilinogen

    Urobilinogen in the urine (mmol/L)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  18. Safety and Tolerability: urinalysis - bilirubin

    Bilirubin in the urine (+/-)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  19. Safety and Tolerability: urinalysis (microscopy) - red blood cells

    Red blood cells in the urine (number in sight)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  20. Safety and Tolerability: urinalysis (microscopy) - white blood cells

    White blood cells in the urine (number in sight)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  21. Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline)

    Cylinders (except hyaline) in the urine (number in sight)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  22. Safety and Tolerability: urinalysis (microscopy) - bacteria

    Bacteria in the urine (number in sight)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  23. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  24. Safety and Tolerability: complete blood count - red blood cells

    Red blood cells, 10\^6/uL

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  25. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  26. Safety and Tolerability: complete blood count - platelets

    Platelets, 10\^3/uL

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  27. Safety and Tolerability: complete blood count - white blood cells

    White blood cells, 10\^3/uL

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  28. Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate, mm per hour

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  29. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  30. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  31. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  32. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  33. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  34. Safety and Tolerability: blood test results - total protein

    Total protein in blood serum, g/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  35. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  36. Safety and Tolerability: blood test results - urea

    Urea in blood serum, mmol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  37. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  38. Safety and Tolerability: blood test results - total bilirubin

    Total bilirubin in blood serum, umol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  39. Safety and Tolerability: blood test results - direct bilirubin

    Direct bilirubin in blood serum, umol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  40. Safety and Tolerability: blood test results - total cholesterol

    Total cholesterol in blood serum, mmol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  41. Safety and Tolerability: blood test results - triglycerides

    Triglycerides in blood serum, mmol/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  42. Safety and Tolerability: blood test results - alanine transaminase (ALT)

    ALT in blood serum, U/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  43. Safety and Tolerability: blood test results - aspartate transaminase (AST)

    AST in blood serum, U/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

  44. Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

    ALP in blood serum, U/L

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)

    Time frame: Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14)

07

Study locations

1 site
  • Limited Liability Company "Research Center Eco-Safety"
    Saint Petersburg, 196143, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05412173
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Apr 22, 2022
Primary completion
May 17, 2022
Completion
Jun 2, 2022
Last update
Jul 27, 2023

Oversight

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

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