A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects

Study Overview
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Brief Summary
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A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.

Official Title
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An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: etynodiol diacetate
* Drug: etynodiol diacetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs). Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femulen commercial tablets<br> | Drug: etynodiol diacetate<br>* tablet, 0.5 mg, single dose<br>|
| Experimental: Femulen reformulated tablets<br> | Drug: etynodiol diacetate<br>* tablet, 0.5 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve to last time point observed (AUCt) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 
| Highest concentration (Cmax) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve to infinity (AUCinf) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 
| Area under the curve percent to infinity (AUC%inf) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 
| Half-life (T1/2) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 
| Time at maximum concentration (Tmax) |  | 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence study, marketed vs reformulation tablets, Femulen