MedTrace Logo

Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

NCT01737203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-01-28

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Viagra

50 mg tablet on Day 1 of each period

DRUG

sildenafil ODT

50 mg tablet on Day 1 of each period

DRUG

sildenafil ODT

50 mg tablet 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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Japan

More Related Trials

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 NCT01737203 on ClinicalTrials.gov