Study Completed

Erectile Dysfunction

Bayer Identifier:

11817

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2006-003624-11

EU CT Number:

Not Available

BAY38-9456, Effect of food and water, res. on PK, 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 - October 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	MEDA Manufacturing GmbH, ClinPharmCologne	Köln, 51063, Germany

Trial design

Randomized, open-label, four-fold crossover study to investigate the effect of a high fat, high calorie breakfast and of water, respectively, on 16 mg vardenafil oral disintegrating tablet in comparison to one 20 mg commercial tablet in healthy, male 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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