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A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.

NCT01260805 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-02-21

No results posted yet for this study

Summary

A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under fasting conditions.

Conditions

  • Bioequivalence
  • Ethinylestradiol
  • Gestodene
  • Harmonet

Interventions

DRUG

Reference Drug

Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose

DRUG

Test Drug

Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01260805 on ClinicalTrials.gov