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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01359163
First received: May 20, 2011
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Therapeutic Equivalency
Drug: etynodiol diacetate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Highest concentration (Cmax) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve to infinity (AUCinf) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
  • Area under the curve percent to infinity (AUC%inf) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
  • Half-life (T1/2) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
  • Time at maximum concentration (Tmax) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femulen commercial tablets Drug: etynodiol diacetate
tablet, 0.5 mg, single dose
Experimental: Femulen reformulated tablets Drug: etynodiol diacetate
tablet, 0.5 mg, single dose

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359163

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01359163     History of Changes
Other Study ID Numbers: B1361002
Study First Received: May 20, 2011
Last Updated: April 3, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
bioequivalence study
marketed vs reformulation tablets
Femulen

Additional relevant MeSH terms:
Ethynodiol Diacetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014