Study Completed

Erectile Dysfunction

Bayer Identifier:

12153

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2006-003314-17

EU CT Number:

Not Available

BAY38-9456 Selection of ERprototype and multiple-dose safety

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

August 2006 - February 2007

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Vardenafil ER (BAY38-9456)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed	Bayer HealthCare	Wuppertal, 42096, Germany

Trial design

Randomized study with a 4-way crossover, single-dose design in stage I to investigate the pharmacokinetics of two 20 mg vardenafil extended-release tablet formulations in the fed and fasted condition in healthy male subjects followed by a subsequent stage II with multiple-dose, placebo-controlled comparison design to investigate the pharmacokinetics, safety, and tolerability of once-daily administration of one of these formulations in healthy male and female subjects

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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