To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed conditions.
Detailed Description : The study was conducted as an Open label, balanced, randomized, two-treatment, two-sequence, two period,single-dose, crossover oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil@PM, of Wyeth Consumer Healthcare, USA., in normal, healthy, adult, human subjects under fed conditions. A total number of forty (40) subjects were enrolled in the study and all the subjects completed both the periods of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
GVK Biosciences Pvt. Ltd
Amīrpet, Hyderabad, India
Bioequivalence study of Dr. Reddys Laboratories Limited, Ibuprofen and Diphenhydramine Citrate Caplets under fasting condition
Time frame: 2 months
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