- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322658
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
December 18, 2014 updated by: Dr. Reddy's Laboratories Limited
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 Fed Conditions.
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 fed conditions.
Study Overview
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 fed conditions.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380 054
- BA Research India Limited
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subjects should be healthy human between 18 and 45 years.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
- The subjects should be able to communicate effectively with study personnel.
The subjects should be able to give written informed consent to participate in the study.
If subject is a female volunteer and
- 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
- Is postmenopausal for at least 1 year or
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion Criteria:
- The subjects who have a history of allergic responses to Eszopiclone or other related drugs.
- The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- 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.
- The subjects who have a history or presence of bronchial asthma.
- Use of enzyme-modification drugs within 30 days prior to receiving the first dose of study medication.
- History of drug dependence, recent history of alcoholism or of moderate alcohol use.
- 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.
- The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
- The subjects who have donated (1 unit 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
- The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
- The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- 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.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast-feeding.
- Female volunteers not willing to use contraception during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eszopiclone Tablets
Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited
|
Other Names:
|
Active Comparator: Lunesta
Lunesta Tablets 3 mg of Sepracor Inc.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve
Time Frame: 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post dose.
|
0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Ronak Modi, MBBS, BA Research India Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
December 18, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA0859147-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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