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Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product

NCT05349396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-04-27

No results posted yet for this study

Summary

This study will investigate the bioavailability in fasting healthy, adult, human subjects of 1 tablet of two formulations containing Eszopiclone 3mg.

The study will be performed at a single site with 28 subjects. Participants will take 1 tablet of the test product 1, and 1 tablet of the test product 2, and reference product in 4 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Eszopiclone 3mg Test Drug T-1 Coated Tablets

Participants will receive one tablet of the test formulation T-1 containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.

DRUG

Eszopiclone 3mg Test Drug T-2 Coated Tablets

Participants will receive one tablet of the test formulation T-2 containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.

DRUG

Eszopiclone 3mg Reference Product Coated Tablets

Participants will receive one tablet of the Rerefence Product containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.

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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2022-04-19
Completion
2022-04-19

Countries

  • India

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 NCT05349396 on ClinicalTrials.gov