Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
- Registration Number
- NCT01170182
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Brief Summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.
- Detailed Description
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
- Subjects who provided written informed consent.
- Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
- Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
- Subjects with normal ECG, chest X-ray (PA view) and vital signs.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Prilosec Prilosec® 40 mg Prilosec® 40 mg Merck \& Co. Inc Omeprazole Omeprazole Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited
- Primary Outcome Measures
Name Time Method Bioequivalence based on Cmax and AUC parameters 4 months
- Secondary Outcome Measures
Name Time Method