Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Phase 1
Completed
- Conditions
- Contraceptives, Postcoital
- Interventions
- Drug: Postinor 2Drug: Levonorgestrel Emergency Pill (BAY86-5028)
- Registration Number
- NCT01073904
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
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.
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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 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 Postinor 2 - Arm 1 Levonorgestrel Emergency Pill (BAY86-5028) -
- Primary Outcome Measures
Name Time Method Least square estimator of average maximum plasmatic concentration (log transformed) After 2 months Least square estimator of area under the pharmacokinetic curve (log transformed) After 2 months
- Secondary Outcome Measures
Name Time Method Time at which maximum concentration is reached After 2 months Area under the pharmacokinetic curve from time=0 to last blood sample After 2 months Half life of plasmatic concentration of study drug After 2 months Clearance constant of plasmatic concentration of study drug After 2 months Adverse events collection Up to 8 weeks