Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
NCT01160029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2010-07-13
Summary
The objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fed conditions.
Conditions
- Healthy
Interventions
- DRUG
-
Nateglinide
Nateglinide Tablets 120 mg
Sponsors & Collaborators
-
Dr. Reddy's Laboratories Limited
lead INDUSTRY
Principal Investigators
-
Antonio R Pizarro, MD · SFBC International, SFBC Miami, Inc. 11190 Biscayne Blvd.Miami, Fl 33181, USA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-10-31
- Primary Completion
- 2004-10-31
- Completion
- 2004-10-31
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