Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
- Registration Number
- NCT01170169
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Brief Summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting 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 44 healthy, adult, human subjects under fasting conditions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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.
Test product, dose, mode of administration and batch number
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Omeprazole Omeprazole Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited Prilosec Prilosec Prilosec® 40 mg of Merck \& Co.Inc.
- Primary Outcome Measures
Name Time Method Bioequivalence based on Cmax and AUC parameters 5 months
- Secondary Outcome Measures
Name Time Method