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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01359163
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
30
Duration (Days)
20.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: etynodiol diacetate
  • Drug: etynodiol diacetate
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Area under the curve to last time point observed (AUCt) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

  2. Highest concentration (Cmax) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

Secondary Outcome Measures

  1. Area under the curve to infinity (AUCinf) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

  2. Area under the curve percent to infinity (AUC%inf) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

  3. Half-life (T1/2) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

  4. Time at maximum concentration (Tmax) [0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Singapore Singapore 188770

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01359163
Other Study ID Numbers:
  • B1361002
First Posted:
May 24, 2011
Last Update Posted:
Apr 4, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Pfizer
bioequivalence study
marketed vs reformulation tablets
Femulen
Additional relevant MeSH terms:
Ethynodiol Diacetate

Study Results

No Results Posted as of Apr 4, 2012