- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073904
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg (LEVEQ-3)
April 1, 2014 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michoacán
-
Morelia, Michoacán, Mexico, 58256
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 2
|
Single dose of 1.5 mg tablet
|
Experimental: Arm 1
|
Single dose of 1.5 mg coated tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Least square estimator of average maximum plasmatic concentration (log transformed)
Time Frame: After 2 months
|
After 2 months
|
Least square estimator of area under the pharmacokinetic curve (log transformed)
Time Frame: After 2 months
|
After 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time at which maximum concentration is reached
Time Frame: After 2 months
|
After 2 months
|
Area under the pharmacokinetic curve from time=0 to last blood sample
Time Frame: After 2 months
|
After 2 months
|
Half life of plasmatic concentration of study drug
Time Frame: After 2 months
|
After 2 months
|
Clearance constant of plasmatic concentration of study drug
Time Frame: After 2 months
|
After 2 months
|
Adverse events collection
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 22, 2010
First Submitted That Met QC Criteria
February 22, 2010
First Posted (Estimate)
February 23, 2010
Study Record Updates
Last Update Posted (Estimate)
April 3, 2014
Last Update Submitted That Met QC Criteria
April 1, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14782
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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