Study Completed

Erectile Dysfunction

Bayer Identifier:

11217

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2006-003692-13

EU CT Number:

Not Available

BAY38-9456, Vardenafil ODT pivotal bioequivalence 16 mg ODT

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

18 - 50 Years

Trial summary

Enrollment Goal

Trial Dates

September 2006 - November 2006

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Vardenafil ODT (BAY38-9456)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed	Institut für Klinische Pharmakologie, Prof. Lücker GmbH	Mannheim, 68167, Germany

Trial design

Randomized, open-label, two-fold crossover study to investigate the bioequivalence of vardenafil after a single dose administration of one 16 mg oral disintegrating tablet in comparison to one 20 mg commercial tablet in healthy male subjects (BAY 38-9456/11217)

Trial Type

Interventional

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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