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

NCT04882826 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ClinPharmInvest, LLC

    collaborator OTHER

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Alexander Khokhlov · ClinPharmInvest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882826 on ClinicalTrials.gov