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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

May 31, 2010
July 26, 2010
February 2006
April 2006   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01170182 on ClinicalTrials.gov Archive Site
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Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Omeprazole
    Omeprazole Delayed Release Capsules 40 mg
    Other Name: Prelosec 40 mg
  • Device: Prilosec® 40 mg
    Prilosec® 40 mg
    Other Name: Omeprazole
  • Experimental: Omeprazole
    Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Omeprazole
  • Active Comparator: Prilosec
    Prilosec® 40 mg Merck & Co. Inc
    Intervention: Device: Prilosec® 40 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2006
April 2006   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01170182
7577/05-06
No
Assistant Manager - Research & Development, Dr. Reddy's Laboratories Limited,
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Manoj K Bose, Dr. Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
Dr. Reddy's Laboratories Limited
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP