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Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin®

NCT06233058 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-01-31

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Drospirenone+ Ethinyl Estradiol Tablets-Test product

Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Umeda Company Limited, Thailand

DRUG

Drospirenone+ Ethinyl Estradiol Tablets-Reference product

Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Manufactured by: Bayer AG, Berlin, Germany

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2024-04-29
Completion
2024-05-27

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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 NCT06233058 on ClinicalTrials.gov