Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01170182
First received: May 31, 2010
Last updated: July 26, 2010
Last verified: May 2010
  Purpose

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.


Condition Intervention Phase
Healthy
Drug: Omeprazole
Device: Prilosec® 40 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2006
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole
Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited
Drug: Omeprazole
Omeprazole Delayed Release Capsules 40 mg
Other Name: Prelosec 40 mg
Active Comparator: Prilosec
Prilosec® 40 mg Merck & Co. Inc
Device: Prilosec® 40 mg
Prilosec® 40 mg
Other Name: Omeprazole

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01170182

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Manoj K Bose, Dr. Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
  More Information

No publications provided

Responsible Party: Assistant Manager - Research & Development, Dr. Reddy's Laboratories Limited,
ClinicalTrials.gov Identifier: NCT01170182     History of Changes
Other Study ID Numbers: 7577/05-06
Study First Received: May 31, 2010
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014