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Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

NCT04230070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-10

No results posted yet for this study

Summary

This Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 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

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug

Bioequivalence

DRUG

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 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
2020-10-24
Primary Completion
2020-10-31
Completion
2020-11-17

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 NCT04230070 on ClinicalTrials.gov