Trials / Completed
CompletedNCT01159158
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
RANDOMIZED, 2-WAY CROSSOVER, BIOEQUIVALENCE STUDY OF NATEGLINIDE 120 mg TABLET AND STARLIX@ ADMINISTERED AS 1 x 120 mg TABLET IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Dr. Reddy's Laboratories Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 fasting conditions.
Detailed description
Single center, bioequivalence, open-label, randomized, 2-way crossover study. 64 + 4 healthy adult male or female, smokers and/or non-smokers. Single oral dose (1 x 120 mg) in each period with a washout of at least 7 days between doses. Dosing with 240 ml of glucose solution (25%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nateglinide | Nateglinide Tablets 120 mg |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2007-02-01
- Completion
- 2007-02-01
- First posted
- 2010-07-09
- Last updated
- 2010-07-13
Source: ClinicalTrials.gov record NCT01159158. Inclusion in this directory is not an endorsement.