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

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.”

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.

Intervention(s) in this Clinical Trial

• Drug: Viagra 50 mg tablet
  • Commercial tablet, 50 mg, single dose administered with water
• Drug: Formulation B ODT tablet 50 mg
  • Oral disintegrating tablet (ODT), 50 mg, single dose administered without water
• Drug: Formulation C ODT tablet 50 mg
  • ODT, 50 mg, single dose administered without water
• Drug: Formulation D ODT tablet 50 mg
  • ODT, 50 mg, single dose, administered without water

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Viagra 50 mg tablet, administered with water.
• Experimental: Formulation B ODT tablet 50 mg, administered without water.
• Experimental: Formulation C ODT tablet 50 mg, administered without water.
• Experimental: Formulation D ODT tablet 50 mg, administered without water.

Primary Measures

• AUC0-T and Cmax of sildenafil
  • Time Frame: 1 month
    Safety Issue?: No

Secondary Measures

• AUC0-Tmax and AUCinf of sildenafil
  • Time Frame: 1 month
    Safety Issue?: No
• Tmax and half-life of sildenafil
  • Time Frame: 1 month
    Safety Issue?: No
• adverse events
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• vital signs
  • Time Frame: 3 weeks
    Safety Issue?: Yes
• laboratory parameters
  • Time Frame: 3 weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00950404

Study ID Number: A1481273

ClinicalTrials.gov Identifier: NCT00950404

Health Authority: United States: Food and Drug Administration

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