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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


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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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