Status and phase
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About
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.
Full 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%).
Enrollment
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Inclusion criteria
Exclusion criteria
Subjects to whom any of the following applies will be excluded from the study:
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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