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Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product

NCT05332106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-18

No results posted yet for this study

Summary

This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg.

The study will be performed at a single site with 10 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 7 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet

Investigational Medicinal Product

DRUG

Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet

Climodien (Bayer plc.)

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Principal Investigators

  • R. Amirtha, MD · Azidus Laboratories Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-12
Primary Completion
2022-03-22
Completion
2022-03-22

Countries

  • India

Study Locations

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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 NCT05332106 on ClinicalTrials.gov