NCT04882826

Bioequivalence Study of Two Formulations of Sildenafil Tablet 100 mg in Healthy Male Volunteers Under Fasting Conditions

Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Sildenafil Tablets 100mg (Pharmtechnology LLC, Belarus) and Viagra® Tablets 100mg (Fareva Amboise, France) in Healthy Male Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Viagra®, 100 mg film-coated tablets) or the test (Sildenafil, 100 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Sildenafil film-coated tablet 100 mg	Sildenafil is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 100 mg of sildenafil.
DRUG	Viagra® film-coated tablet 100 mg	Viagra® is manufactured by Fareva Amboise, France. Each tablet contains 100 mg of sildenafil.

Timeline

• Start date: 2021-05-10
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2021-05-12
• Last updated: 2021-05-12

Locations

1 site across 1 country: Russia