Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Sildenafil Citrate

Criteria

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 Informed Consent.

Exclusion Criteria:

• Evidence or history of clinically significant abnormalities

• Have baseline orthostatic hypotension

• Positive drug screen, excessive alcohol and tobacco use