NCT05349396

Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product

Bioavailability of Two Formulations of Eszopiclone 3.0 mg Coated Tablets With Regards to the Marketed Reference Product

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of the study is to investigate the relative bioavailability of Eszopiclone 3mg of 1 tablet of 2 formulations with Eszopiclone 3mg and to demonstrate bioequivalence of the three formulations in terms of rate and extent of absorption: * Test Product T-1: Product manufactured by Laboratorios Silesia S.A. * Test Product T-2: Product manufactured by Laboratorios Andromaco S.A. * Reference Product: Lunesta \[Trademark\], product of Sunovion Pharmaceuticals Inc. The 90% confidence intervals for the intra-subject coefficient of variation (Test products T1/T2 versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0-t), and maximum plasma concentration (Cmax) for total Eszopiclone will be determined. Participants will be confined in the study site for approximately 9 days during the entire study (for 10 hours pre-dosing and for 24 hours post dosing after period IV) during which pharmacokinetic (PK) blood samples will be obtained. 24 blood samples will be taken up to 24 hours after the administration in each period. The washout period between the four study periods will be at least 2 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Eszopiclone in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-11
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2022-04-27
• Last updated: 2022-04-27

Locations

1 site across 1 country: India