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

NCT04882826 PHASE1 UNKNOWN

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

Details

Lead sponsor	Pharmtechnology LLC
Phase	PHASE1
Status	UNKNOWN
Enrolment	44
Start date	Mon May 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun May 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Bioequivalence

Interventions

• Sildenafil film-coated tablet 100 mg
• Viagra® film-coated tablet 100 mg

Countries

Russia