Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Eszopiclone Tablets 3 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Dr. Ronak Modi, MBBS, Principal Investigator, Affiliation: BA Research India Limited
Summary
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single
dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting
conditions.
Clinical Details
Official title: An Open Label, Balanced, Randomized, Two-Treatment, Two Period, Two-Sequence, Single Dose, Crossover, Oral Bioequivalence Study Of Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited, and 'LUNESTA' Tablets 3 mg, Mfg For Sepracor Inc. USA In Healthy Adult Human Subjects Under Fasting Conditions.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under curve
Detailed description:
An open label, balanced, randomized, two-treatment, two-period, two-sequence,single dose,
crossover, oral bioequivalence study of Eszopiclone tablets 3 mg of Dr. Reddy's Laboratories
limited, and 'LUNESTA' tablets 3 mg Mfg for Sepracor Inc. USA in healthy adult human
subjects under fasting conditions.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. The subjects should be healthy human between 18 and 45 years.
2. The subjects should be screened within 21 days prior to the administration of first
dose of the study drug.
3. The subjects should have a BMI between 18. 5 and 24. 9 weight in kg/ height2 in meter.
4. The subjects should be able to communicate effectively with study personnel.
5. The subjects should be able to give written informed consent to participate in the
study.
If subject is a female volunteer and
6. Is of child bearing potential practicing an acceptable method of birth control for
the duration of the study as judged by the investigator(s), such as condoms, foams,
jellies, diaphragm, intrauterine device (IUD), or abstinence or
7. Is postmenopausal for at least 1 year or
8. Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the subject).
Exclusion Criteria:
1. The subjects who have a history of allergic responses to Eszopiclone or other related
drugs.
2. The subjects who have significant diseases or clinically significant abnormal
findings during screening, medical history, physical examination, laboratory
evaluations, ECG and X-ray recordings.
3. The subjects who have any disease or condition which might compromise the
haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central
nervous system, diabetes, psychosis or any other body system.
4. The subjects who have a history or presence of bronchial asthma.
5. Use of enzyme-modification drugs within 30 days prior to receiving the first dose of
study medication.
6. History of drug dependence, recent history of alcoholism or of moderate alcohol use.
7. The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or
more than or equal to 20 biddies per day or those who cannot refrain from smoking
during study period.
8. The subjects with a history of difficulty with donating blood or difficulty in
accessibility of veins.
9. The subjects who have donated (1 unit 350 ml / 450 ml) blood within 90 days prior to
receiving the first dose of study medication.
10. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
11. The subjects who have a positive test result for HIV antibody and / or syphilis
(RPR/VDRL).
12. The subject who receives an investigational product, or has participated in a drug
research study within a period of 90 days prior to the first dose of the study
medication administration.
13. Female volunteers demonstrating a positive pregnancy screen.
14. Female volunteers who are currently breast-feeding.
15. Female volunteers not willing to use contraception during the study.
Locations and Contacts
BA Research India Limited, Ahmedabad, Gujarat 380 054, India
Additional Information
Starting date: August 2008
Last updated: December 18, 2014
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