NCT04268472

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	GP30101	Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
DRUG	Prezista®	Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
DRUG	GP30101	Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
DRUG	Prezista®	Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer

Timeline

• Start date: 2019-06-06
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2020-02-13
• Last updated: 2024-07-22

Locations

1 site across 1 country: Russia