This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in healthy, adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product: Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA, under fed condition in healthy, adult, human subjects in a randomized crossover study. The study was conducted with 36 healthy adult subjects. In each study period, a single 300 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position. The duration of the clinical phase was approximately 10 days including washout period of 7 days between administrations of study drug in each study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
300 mg capsule once a day
500 mg tablet once a day
Veeda Clinical Research Pvt. Ltd.
Ahmedabad, Gujarat, India
Cmax
Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.
Time frame: 2 months
AUC
Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.
Time frame: 2 months
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