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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel — LEVEQ-1  

Contraception Clinical Trial

Official title:
Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01096485
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date February 2009
Completion date March 2009
View Details
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