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OpenTrials
Completed

NCT Number: NCT01359163

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

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

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Key information

Conditions

Therapeutic Equivalency

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

etynodiol diacetate

Drug

tablet, 0.5 mg, single dose

Primary outcomes

  1. Area under the curve to last time point observed (AUCt)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

  2. Highest concentration (Cmax)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

Secondary outcomes

  1. Area under the curve to infinity (AUCinf)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

  2. Area under the curve percent to infinity (AUC%inf)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

  3. Half-life (T1/2)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

  4. Time at maximum concentration (Tmax)

    Time frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 24, 2011
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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