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

Therapeutic Equivalency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359163
• Other study ID #: B1361002
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2011
• Last updated: April 3, 2012
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

Drug:
• etynodiol diacetate
tablet, 0.5 mg, single dose
• etynodiol diacetate
tablet, 0.5 mg, single dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve to last time point observed (AUCt)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	No
Primary	Highest concentration (Cmax)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	No
Secondary	Area under the curve to infinity (AUCinf)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	No
Secondary	Area under the curve percent to infinity (AUC%inf)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	No
Secondary	Half-life (T1/2)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	No
Secondary	Time at maximum concentration (Tmax)		0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48	Yes

External Links

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