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Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268472
Recruitment Status : Completed
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Geropharm

Brief Summary:
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: GP30101 Drug: Prezista® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment two-way crossover
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : June 6, 2019
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine


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)
Drug: GP30101
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Name: First aIntervention Period

Drug: Prezista®
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Name: Second Intervention Period

Experimental: RT Sequence
In first Intervention period subjects was administered reference medecine (Prezista) and in seconde Intervention period subjects was administered test medecine (GP30101)
Drug: Prezista®
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Name: First aIntervention Period

Drug: GP30101
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other Name: Second Intervention Period




Primary Outcome Measures :
  1. 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 ]
    Pharmacokinetics by Assessment of Observed Maximum Plasma Concentration (Cmax)

  2. 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 ]
    Pharmacokinetics by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)


Secondary Outcome Measures :
  1. 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 ]
    Pharmacokinetics by Assessment of Time of Maximum concentration observed (T(max)

  2. 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 ]
    Pharmacokinetics by Assessment of elimination half-life T(1/2)

  3. 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 ]
    Pharmacokinetics by Assessment of elimination rate constant



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268472


Locations
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Russian Federation
Yarosslavl Clinical Hospital #3
Yaroslavl, Russian Federation
Sponsors and Collaborators
Geropharm

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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT04268472    
Other Study ID Numbers: GP30101-P4-11
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents