Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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