Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
LEVEQ-2
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
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedJune 11, 2013
June 1, 2013
28 days
March 30, 2010
June 8, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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 event collection
Up to 8 weeks
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Morelia, Michoacán, 58256, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2010
First Posted
March 31, 2010
Study Start
February 1, 2009
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
June 11, 2013
Record last verified: 2013-06