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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraceptives, Postcoital

Intervention: Levonorgestrel Emergency Pill (BAY86-5028) (Drug); Postinor 2 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

Clinical Details

Official title: Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers

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

Primary outcome:

Least square estimator of average maximum plasmatic concentration (log transformed)

Least square estimator of area under the pharmacokinetic curve (log transformed)

Secondary outcome:

Time at which maximum concentration is reached

Area under the pharmacokinetic curve from time=0 to last blood sample

Half life of plasmatic concentration of study drug

Clearance constant of plasmatic concentration of study drug

Adverse events collection


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


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 tobacco or alcohol abuse or regular use of recreational or therapeutic


- 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.

Locations and Contacts

Morelia, Michoacán 58256, Mexico
Additional Information

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Starting date: September 2009
Last updated: April 1, 2014

Page last updated: August 23, 2015

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