Trial Condition(s):
Contraception
Cross -over study to prove bioequivalence between two oral formulations of levonorgestrel (LEVEQ-2)
Bayer Identifier:
14355
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Clinica de Enfermedades Cronicas y Procedimientos Especiales Morelia, Mexico, 58256 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, randomized, crossover study to prove bioequivalence between Opxion® (levonorgestrel 0.75 mg from Bayer de Mexico) and Postday® (levonorgestrel 0.75 mg from Investigacion Farmaceutica), in healthy volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Least square estimator of average maximum plasmatic concentration (log transformed)Timeframe: After 2 months
- Least square estimator of area under the pharmacokinetic curve (log transformed)Timeframe: After 2 months
Secondary Outcome
- Time at which maximum concentration is reachedTimeframe: After 2 months
- Area under the pharmacokinetic curve from time=0 to last blood sampleTimeframe: After 2 months
- Half life of plasmatic concentration of study drugTimeframe: After 2 months
- Clearance constant of plasmatic concentration of study drugTimeframe: After 2 months
- Adverse event collectionTimeframe: Up to 8 weeks
Additional Information
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