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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: etynodiol diacetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359163

B1361002

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Femulen commercial tablets

Active Comparator group

Treatment:

Drug: etynodiol diacetate

Drug: etynodiol diacetate

Femulen reformulated tablets

Experimental group

Treatment:

Drug: etynodiol diacetate

Drug: etynodiol diacetate