A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedApril 4, 2012
April 1, 2012
1 month
May 20, 2011
April 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the curve to last time point observed (AUCt)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Highest concentration (Cmax)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Secondary Outcomes (4)
Area under the curve to infinity (AUCinf)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Area under the curve percent to infinity (AUC%inf)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Half-life (T1/2)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Time at maximum concentration (Tmax)
0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Study Arms (2)
Femulen commercial tablets
ACTIVE COMPARATORFemulen reformulated tablets
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 24, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
April 4, 2012
Record last verified: 2012-04