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Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet

NCT00950404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-02-01

No results posted yet for this study

Summary

The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Viagra 50 mg tablet

Commercial tablet, 50 mg, single dose administered with water

DRUG

Formulation B ODT tablet 50 mg

Oral disintegrating tablet (ODT), 50 mg, single dose administered without water

DRUG

Formulation C ODT tablet 50 mg

ODT, 50 mg, single dose administered without water

DRUG

Formulation D ODT tablet 50 mg

ODT, 50 mg, single dose, administered without water

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
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

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 NCT00950404 on ClinicalTrials.gov