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

Phase 1

Completed

• Conditions: Therapeutic Equivalency
• Interventions: Drug: etynodiol diacetate

• Registration Number: NCT01359163
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Femulen commercial tablets	etynodiol diacetate	-
Femulen reformulated tablets	etynodiol diacetate	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore