Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
NCT02322645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2014-12-23
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.
Conditions
- Healthy
Interventions
- DRUG
-
Eszopiclone Tablets 3 mg
Sponsors & Collaborators
-
Dr. Reddy's Laboratories Limited
lead INDUSTRY
Principal Investigators
-
Dr. Ronak Modi, MBBS · BA Research India Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-10-31
Countries
- India
Study Locations
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