- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268472
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
February 12, 2020 updated by: Geropharm
Crossover, Open-label, Randomized, Single-dose, Bioequivalence Study of GP30101 Film-coated Tablets (LLC "GEROPHARM", Russia) 800 mg Versus Prezista® (Jonson&Jonson, Russia) Film-coated Tablets 800 mg in Healthy Volunteers Under Fed Conditions
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
Study Overview
Detailed Description
Study to evaluate the pharmacokinetic parameters, relative bioavailability and bioequivalence of drugs containing darunavir - GP30101 and Prezista® in healthy volunteers after single orally administered dose, under fed conditions A comparative analysis of adverse events aditionally conducted in this study.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Yaroslavl, Russian Federation
- Yarosslavl Clinical Hospital #3
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Signed informed consent form.
- Male aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Body mass index between 18,5 and 30 kg/m2, with body weight 60-100 kg
- Consent to comply with an adequate method of effective contraception throughout the study.
- The consent of volunteers to all restrictions imposed during the study.
- Russian Federation Citizens
Exclusion Criteria:
- History of allergic problems/events.
- Hypersensitivity to heparin, darunavir or any of the excipients of the drugs studied.
- Any acute and chronic diseases, including but not limited to cardiovascular system diseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Positive testing for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
- The WHO norms deviations of the heart rate (60-89), Sistolic BP (100-130 mm Hg), Diatolic BP (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7 - 37.6 °C).
- Abnormal ECG during screening.
- Inaccessible veins of the upper extremities, vein thrombosis, thrombophlebitis in the anamnesis or in the family history of the next of kin, "compromised" veins due to frequent previous venipuncture.
- Psychiatric disorders, history of epilepsy and seizures.
- Surgical interventions on the gastrointestinal tract (except appendectomy).
- Acute infectious diseases in less than 4 weeks before the start of the study.
- Regular medication use (intake) less than 2 weeks before the start of the study.
- Significant loss of blood within 3 months prior to screening, including but not limited to blood donation or extended surgery or trauma resulting in the blood loss.
- History of alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Positive test results for alcohol or drug use.
- Nicotine addiction, regular use of tobacco, including all types of electronic cigarettes, less than 6 months prior to screening.
- Participation in a clinical trial of any drugs (including experimental) or experimental medical devices for 3 months or 5 half-lives, whichever is longer, before the study.
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- Any diet (for example, vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity) that may interfere with the study.
- Taking medications that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the start of the study.
- Volunteers who are obvious or likely, according to the investigator, are unable to understand and evaluate the information on this study as part of the process of signing informed consent, in particular regarding the expected risks and possible discomfort.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TR Sequence
In first Intervention period subjects was administered test medecine (GP30101) and in seconde Intervention period subjects was administered reference medecine (Prezista)
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Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Names:
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Names:
|
Experimental: RT Sequence
In first Intervention period subjects was administered reference medecine (Prezista) and in seconde Intervention period subjects was administered test medecine (GP30101)
|
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Names:
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C(max)
Time Frame: -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Pharmacokinetics by Assessment of Observed Maximum Plasma Concentration (Cmax)
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-35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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AUC(0-t)
Time Frame: -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Pharmacokinetics by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)
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-35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T(max)
Time Frame: -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Pharmacokinetics by Assessment of Time of Maximum concentration observed (T(max)
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-35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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T(1/2)
Time Frame: -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Pharmacokinetics by Assessment of elimination half-life T(1/2)
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-35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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K(e)
Time Frame: -35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Pharmacokinetics by Assessment of elimination rate constant
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-35 min prior dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2019
Primary Completion (Actual)
September 6, 2019
Study Completion (Actual)
September 6, 2019
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 12, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GP30101-P4-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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