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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

Page last updated: August 23, 2015

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