Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Phase 1
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Registration Number
- NCT01254383
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
Signed and dated informed consent document.
Exclusion Criteria
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C Sildenafil ODT Sildenafil ODT tablet 50 mg, administered with water under fasted conditions. Treatment A Sildenafil Tablet Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions Treatment B Sildenafil ODT Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
- Primary Outcome Measures
Name Time Method AUC(0-t) of sildenafil. Up to 1 month Cmax of sildenafil. Up to 1 month
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events. Up to 1 month AUC(0-inf) of sildenafil, if data permits. Up to 1 month Half-life of sildenafil, if data permits. Up to 1 month Tmax of sildenafil. Up to 1 month
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore