An interventional study of Antareit in Heartburn, Acid-dependent Diseases of the Gastrointestinal Tract and Symptomatic Treatment of Gastric and Duodenal Ulcers, sponsored by Valenta Pharm JSC. Recruiting at 2 sites in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Valenta Pharm JSC · Not applicable, Interventional, and Other
Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg/10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Withdrawal criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 (25 volunteers, TR sequence) will take 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 1 and 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 2
Drug: Antareit
Group 2 (25 volunteers, RT sequence) will take 2 tablets of Riopan 800 mg chewable tablets 2 h prior to food intake in Period 1 and 2 sachets of Antareit 800 mg/10 ml oral suspension 2 h prior to food intake in Period 2
Drug: Antareit
A single dose of T or R drug in each of 2 periods of the study 2 h prior to food intake
Pharmacodynamics - AUCpH - Area under the curve potential of hydrogen
Area under the pharmacodynamic pH-time curve
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 4.0
PH - potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmaximum
maximum potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics- рНmin
minimum potential of hydrogen
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - average pH value
root mean square
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - time percentage during which the intragastric pH value will exceed 3.0
During which the intragastric pH value will exceed 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 3.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
Pharmacodynamics - median time when the pH was above 4.0
Time frame: From 0 to 1 hour (Day 1 and Day 8)
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 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)
Safety and Tolerability: serious adverse event (SAE) number and frequency
Number and frequency of serious AEs (SAEs)
Time frame: From the screening (and signing informed consent form) to Day 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)
Safety and Tolerability: volunteer complaints
Time frame: From the screening (and signing informed consent form) to Day 15 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 15)
Safety and Tolerability: physical examination results
Physical examination will be conducted to identify normal and abnormal physical characteristics of volunteers in accordance with the planned examination and will include an assessment of the Condition of the cardiovascular, respiratory, digestive, endocrine, musculoskeletal, nervous, sensory systems, skin/visible mucous membranes
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 15)
Safety and Tolerability: vital signs
systolic blood pressure (SBP),diastolic blood pressure (DBP), heart rate (HR), body temperature
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 15)
Safety and Tolerability: 12-lead electrocardiogram (ECG)
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 legб V1-V6) taken while lying down: heart rate (beats per minute), 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), QRS complex (The QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram), corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave)
Time frame: Screening, Day 9
Safety and Tolerability: clinical blood test
hemoglobin, hematocrit, Red blood cell count, Platelet count, Leukocyte count, erythrocyte sedimentation rate, Leukocyte formula (myelocytes, band neutrophils, segmented neutrophils, eosinophils, basophils, monocytes, lymphocytes)
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: blood chemistry
Glucose concentration, Total cholesterol concentration, Total protein concentration, Total bilirubin concentration, Creatinine concentration, Alkaline phosphatase activity, alanine transaminase and aspartate transaminase activity
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis
Relative density, Color, Transparency, pH, Protein concentration, Glucose concentration, Red blood cell content, White blood cell content, Epithelial cell content, Presence of casts, Presence of mucus, Presence of bacteria.
Time frame: Screening, Day 2, Day 9
Safety and Tolerability: urinalysis (microscopy)
Microscopy of urine sediment is performed if it is present.
Time frame: Screening, Day 2, Day 9
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Oct 2024, 5 months after the start.
Of 26 interventional studies with no phase under Heartburn, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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