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Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01170169
First received: May 31, 2010
Last updated: July 26, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Omeprazole
Drug: Prilosec
 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 Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2006
Study Completion Date: March 2006
Primary Completion Date: March 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 of Merck & Co.Inc.
 Drug: Prilosec
Prilosec® 40 mg of Merck & Co.Inc.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.

Test product, dose, mode of administration and batch number

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170169

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Majoj K Bose 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: NCT01170169     History of Changes
Other Study ID Numbers: 7566/05-06
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 17, 2012