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Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product

NCT04713904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-04-15

No results posted yet for this study

Summary

The study will be performed at a single site with 38 subjects. Participantswill 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

Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets

Investigational Medicinal Product

DRUG

Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets

Evafem 20 (Trademark)

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
2021-01-16
Primary Completion
2021-01-16
Completion
2021-02-02

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 NCT04713904 on ClinicalTrials.gov