check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:
11199
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
2006-003693-96
EU CT Number:
Not Available
BAY38-9456, Vardenafil ODT pivotal bioequivalence 3.5 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
100
Trial Dates
August 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

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Trial design

Randomized, open-label, two-fold crossover study to investigate the bioequivalence of vardenafil after a single dose administration of one 3.5 mg oral disintegrating tablet in comparison to one 5 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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