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

Contraception Clinical Trial

— LEVEQ-1  

Official title:

Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096485
• Other study ID #: 13956
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2010
• Last updated: June 9, 2013
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Contraception
• Contraception, Postcoital

Intervention

Drug:
• Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Single dose of 1.5 mg coated tablet
• Levonorgestrel (Postday)
Single dose of two 0.75 mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least square estimator of average maximum plasmatic concentration (log transformed)		After 2 months	No
Primary	Least square estimator of area under the pharmacokinetic curve (log transformed)		After 2 months	No
Secondary	Time at which maximum concentration is reached		After 2 months	No
Secondary	Area under the pharmacokinetic curve from time=0 to time of last blood sample		After 2 months	No
Secondary	Clearance constant of plasmatic concentration of study drug		After 2 months	No
Secondary	Half life of plasmatic concentration of study drug		After 2 months	No
Secondary	Adverse events collection		Up to 8 weeks	Yes

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