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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.