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

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268472
• Other study ID #: GP30101-P4-11
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: February 2020
• Source: Geropharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• GP30101
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
• Prezista®
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
• GP30101
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
• Prezista®
Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer

Locations

Country	Name	City	State
Russian Federation	Yarosslavl Clinical Hospital #3	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Geropharm

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C(max)	Pharmacokinetics by Assessment of Observed Maximum Plasma Concentration (Cmax)	-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
Primary	AUC(0-t)	Pharmacokinetics by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t)	-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	T(max)	Pharmacokinetics by Assessment of Time of Maximum concentration observed (T(max)	-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	T(1/2)	Pharmacokinetics by Assessment of elimination half-life T(1/2)	-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	K(e)	Pharmacokinetics by Assessment of elimination rate constant	-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