Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
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 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Majoj K Bose, 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 fasting 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 Fasting Conditions
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 44 healthy, adult, human subjects under fasting conditions.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Test product, dose, mode of administration and batch number
Locations and Contacts
Additional Information
Starting date: January 2006
Last updated: July 26, 2010
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