Overview

Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
Male
Summary
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
Treatments:
Levonorgestrel
Criteria
Inclusion Criteria:

- Healthy male volunteers age between 18 and 55 years old with normal vital signs,
electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

- History of illnesses or any organic abnormalities that could affect the results of the
study.

- History of abuse tobacco or alcohol or regular use of recreational or therapeutic
drugs.

- Subjects that have taken any medication within 14 days or that are in an elimination
period of less than 7 half-lives (whichever is longest) before study startup.