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Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product

NCT04193852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-12-10

No results posted yet for this study

Summary

This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg.

The Pilot study will be performed at a single site with 10 subjects. Participants will take 2 tablets 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 14 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug

Coated Tablets

DRUG

Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product

Coated Tablets

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Principal Investigators

  • Study Director Laboratorios Andromaco · Grünenthal Group

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
2019-11-09
Primary Completion
2019-11-12
Completion
2019-11-25

Countries

  • Chile

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 NCT04193852 on ClinicalTrials.gov