Bioequivalence Clinical Trial
Official title:
Bioavailability of Two Formulations of Eszopiclone 3.0 mg Coated Tablets With Regards to the Marketed Reference Product
Verified date | April 2022 |
Source | Laboratorios Andromaco S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 19, 2022 |
Est. primary completion date | April 19, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination. 3. Normal or clinically insignificant biochemical, hematological, urine and serology parameters. 4. Normal or clinically insignificant ECG. 5. 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. 6. 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. 7. Volunteers who can give written informed consent and communicate effectively. Exclusion Criteria: 1. History of any major surgical procedure in the past 03 months. 2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders. 3. History of chronic alcoholism/ chronic smoking/ drug of abuse. 4. Volunteers with known hypersensitivity to Eszopiclone or any of the excipients. 5. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing 6. Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1&2) antibodies. 7. 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. 8. History of consumption of grapefruit and/or its products within 10 days prior to the start of study. 9. Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in. 10. 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. 11. Volunteers who are dysphagic. |
Country | Name | City | State |
---|---|---|---|
India | Azidus Laboratories Ltd. | Chennai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Andromaco S.A. |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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