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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170182
First Posted: July 27, 2010
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dr. Reddy's Laboratories Limited
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 31, 2010
First Posted: July 27, 2010
Last Update Posted: July 27, 2010
Last Verified: May 2010

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