Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

• 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 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