Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product

NCT05349396 | Completed Phase 1

• 1 other identifier: HP8821-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Total Eszopiclone: area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24)

  24 samples up to 24 hours will be taken after the administration in each period

  From intake and up to 24 hours after tablet intake

• Total Eszopiclone: area under the plasma concentration-time curve from 0 to time t hours (AUC 0-t)

  24 samples up to 24 hours will be taken after the administration in each period

  From intake and up to 24 hours after tablet intake

• Total Eszopiclone: Maximum plasma concentration (Cmax)

  24 samples up to 24 hours will be taken after the administration in each period

  From intake and up to 24 hours after tablet intake

• Total Eszopiclone: Time to achieve maximum plasma concentration (tmax)

  24 samples up to 24 hours will be taken after the administration in each period

  From intake and up to 24 hours after tablet intake

Study Arms (3)

Eszopiclone Test Product T-1

EXPERIMENTAL

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

Drug: Eszopiclone 3mg Test Drug T-1 Coated Tablets

Eszopiclone Test Product T-2

EXPERIMENTAL

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

Drug: Eszopiclone 3mg Test Drug T-2 Coated Tablets

Eszopiclone Referent Product

ACTIVE COMPARATOR

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

Drug: Eszopiclone 3mg Reference Product Coated Tablets

Interventions

Eszopiclone 3mg Test Drug T-1 Coated Tablets DRUG

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.

Also known as: Investigational Medicinal Product 1

Eszopiclone Test Product T-1

Eszopiclone 3mg Test Drug T-2 Coated Tablets DRUG

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.

Also known as: Investigational Medicinal Product 2

Eszopiclone Test Product T-2

Eszopiclone 3mg Reference Product Coated Tablets DRUG

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

Also known as: Lunesta (Trademark)

Eszopiclone Referent Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
• Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• Normal or clinically insignificant ECG.
• Negative urine test for drugs of abuse for both males and females and negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
• Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for at least 1 month after the last drug administration.
• Volunteers who can give written informed consent and communicate effectively.

You may not qualify if:

• History of any major surgical procedure in the past 03 months.
• History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• History of chronic alcoholism/ chronic smoking/ drug of abuse.
• Volunteers with known hypersensitivity to Eszopiclone or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Eszopiclone or any other medication judged to be clinically significant by the investigator.
• History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• History of consumption of one or more of the below, 48 hours prior to dosing:
• Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
• Volunteers who are dysphagic.

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Azidus Laboratories Ltd.

Chennai, Tamil Nadu, 600048, India

Location

MeSH Terms

Interventions

Eszopiclone; Patents as Topic

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Intellectual Property; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 27, 2022
• Study Start: April 11, 2022
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)