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A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form

NCT04391868 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-02-15

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence of Sildenafil ODF 50 mg to Viagra® tablet 50 mg under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Viagra Tablet

50 mg tablet on Day 1 of each period

DRUG

Sildenafil Citrate ODF

50 mg ODF on Day 1 of each period

DRUG

Sildenafil Citrate ODF

50 mg ODF on Day 1 of each period

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2021-04-28
Completion
2021-04-28
FDA Drug
Yes

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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 NCT04391868 on ClinicalTrials.gov