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Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT02322658
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief 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 fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Eszopiclone Tablets 3 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Fed Conditions.
Study Start Date : September 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Eszopiclone

Arm Intervention/treatment
Experimental: Eszopiclone Tablets
Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited
Drug: Eszopiclone Tablets 3 mg
Other Name: Lunesta

Active Comparator: Lunesta
Lunesta Tablets 3 mg of Sepracor Inc.
Drug: Eszopiclone Tablets 3 mg
Other Name: Lunesta




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322658


Locations
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India
BA Research India Limited
Ahmedabad, Gujarat, India, 380 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. Ronak Modi, MBBS BA Research India Limited

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02322658     History of Changes
Other Study ID Numbers: BA0859147-01
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs