Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Omeprazole (Drug); Prilosec® 40 mg (Device)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Manoj K Bose, Dr., Principal Investigator, Affiliation: Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
Summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules
under fed condition.
Clinical Details
Official title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on Cmax and AUC parameters
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: February 2006
Last updated: July 26, 2010
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