Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Formulation B ODT tablet 50 mgDrug: Formulation C ODT tablet 50 mgDrug: Formulation D ODT tablet 50 mg
- Registration Number
- NCT00950404
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Viagra 50 mg tablet, administered with water. Viagra 50 mg tablet - Formulation B ODT tablet 50 mg, administered without water. Formulation B ODT tablet 50 mg - Formulation C ODT tablet 50 mg, administered without water. Formulation C ODT tablet 50 mg - Formulation D ODT tablet 50 mg, administered without water. Formulation D ODT tablet 50 mg -
- Primary Outcome Measures
Name Time Method AUC0-T and Cmax of sildenafil 1 month
- Secondary Outcome Measures
Name Time Method vital signs 3 weeks AUC0-Tmax and AUCinf of sildenafil 1 month Tmax and half-life of sildenafil 1 month laboratory parameters 3 weeks adverse events 3 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States