Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
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 |
---|---|---|
|
Phase 1 |
Study Design
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
- AUC0-T and Cmax of sildenafil [1 month]
Secondary Outcome Measures
- AUC0-Tmax and AUCinf of sildenafil [1 month]
- Tmax and half-life of sildenafil [1 month]
- adverse events [3 weeks]
- vital signs [3 weeks]
- laboratory parameters [3 weeks]
Eligibility Criteria
Criteria
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.- A1481273