NCT05412173

Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers

A Randomized, Open-label, Cross-over Adaptive Study of the Comparative Pharmacokinetics and Bioequivalence of the Drugs Molnupiravir, Capsules, 200 mg and Lagevrio, Capsules, 200 mg in Healthy Volunteers at Fasted Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs); 2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.

Conditions

• Viral Infection
• COVID-19

Interventions

Type	Name	Description
DRUG	Molnupiravir	A single dose of R or T drug in each of 2 periods of the study in fasted conditions

Timeline

• Start date: 2022-04-22
• Primary completion: 2022-05-17
• Completion: 2022-06-02
• First posted: 2022-06-09
• Last updated: 2023-07-27

Locations

1 site across 1 country: Russia