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Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product

NCT04422028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-09

No results posted yet for this study

Summary

This Pivotal study investigated the bioavailability in women of 2 tablet formulations containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30 subjects. Participants took 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 14 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Desogestrel 0.075 MG

Test Drug

DRUG

Desogestrel 0.075 MG

Reference Product

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Principal Investigators

  • Study Director Study Director · Laboratorios Andromaco

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
2020-01-11
Primary Completion
2020-01-11
Completion
2020-01-28

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 NCT04422028 on ClinicalTrials.gov