Status:
COMPLETED
Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Bioequivalence
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
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 f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05349396
Start Date
April 11 2022
End Date
April 19 2022
Last Update
April 27 2022
Active Locations (1)
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1
Azidus Laboratories Ltd.
Chennai, Tamil Nadu, India, 600048