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Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

NCT04230083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-18

No results posted yet for this study

Summary

This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 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 14 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Dienogest 2.0 mg Test Drug

Bioequivalence

DRUG

Dienogest 2.0 mg Reference Product

Bioequivalence

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    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
2019-12-07
Primary Completion
2019-12-10
Completion
2019-12-24

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 NCT04230083 on ClinicalTrials.gov