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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00950404
Collaborator
(none)
16
1
4
1
15.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Viagra 50 mg tablet
  • Drug: Formulation B ODT tablet 50 mg
  • Drug: Formulation C ODT tablet 50 mg
  • Drug: Formulation D ODT tablet 50 mg
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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.
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Viagra 50 mg tablet, administered with water.

Drug: Viagra 50 mg tablet
Commercial tablet, 50 mg, single dose administered with water

Experimental: Formulation B ODT tablet 50 mg, administered without water.

Drug: Formulation B ODT tablet 50 mg
Oral disintegrating tablet (ODT), 50 mg, single dose administered without water

Experimental: Formulation C ODT tablet 50 mg, administered without water.

Drug: Formulation C ODT tablet 50 mg
ODT, 50 mg, single dose administered without water

Experimental: Formulation D ODT tablet 50 mg, administered without water.

Drug: Formulation D ODT tablet 50 mg
ODT, 50 mg, single dose, administered without water

Outcome Measures

Primary Outcome Measures

  1. AUC0-T and Cmax of sildenafil [1 month]

Secondary Outcome Measures

  1. AUC0-Tmax and AUCinf of sildenafil [1 month]

  2. Tmax and half-life of sildenafil [1 month]

  3. adverse events [3 weeks]

  4. vital signs [3 weeks]

  5. laboratory parameters [3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site New Haven Connecticut United States 06511

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00950404
Other Study ID Numbers:
  • A1481273
First Posted:
Jul 31, 2009
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2021