Overview
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
Status:
Completed
Completed
Trial end date:
2008-10-01
2008-10-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Dr. Reddy's Laboratories LimitedTreatments:
Eszopiclone
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.