FindTrial
Sign In

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

An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil Without Water Relative To Viagra Conventional Oral Tablet With Water.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950404
Enrollment
16
Registered
2009-07-31
Start date
2009-08-31
Completion date
2009-09-30
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Bioavailability Pharmacokinetic Formulation

Brief 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.

Interventions

DRUGViagra 50 mg tablet

Commercial tablet, 50 mg, single dose administered with water

DRUGFormulation B ODT tablet 50 mg

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

DRUGFormulation C ODT tablet 50 mg

ODT, 50 mg, single dose administered without water

DRUGFormulation D ODT tablet 50 mg

ODT, 50 mg, single dose, administered without water

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects * Weight: BMI from 17.5 to 30.5

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * A positive urine drug screen.

Design outcomes

Primary

MeasureTime frame
AUC0-T and Cmax of sildenafil1 month

Secondary

MeasureTime frame
laboratory parameters3 weeks
vital signs3 weeks
AUC0-Tmax and AUCinf of sildenafil1 month
Tmax and half-life of sildenafil1 month
adverse events3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026