search
Back to results

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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Omeprazole
Prilosec® 40 mg
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Omeprazole

    Prilosec

    Arm Description

    Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited

    Prilosec® 40 mg Merck & Co. Inc

    Outcomes

    Primary Outcome Measures

    Bioequivalence based on Cmax and AUC parameters

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2010
    Last Updated
    July 26, 2010
    Sponsor
    Dr. Reddy's Laboratories Limited
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01170182
    Brief Title
    Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Dr. Reddy's Laboratories Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omeprazole
    Arm Type
    Experimental
    Arm Description
    Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited
    Arm Title
    Prilosec
    Arm Type
    Active Comparator
    Arm Description
    Prilosec® 40 mg Merck & Co. Inc
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole
    Other Intervention Name(s)
    Prelosec 40 mg
    Intervention Description
    Omeprazole Delayed Release Capsules 40 mg
    Intervention Type
    Device
    Intervention Name(s)
    Prilosec® 40 mg
    Other Intervention Name(s)
    Omeprazole
    Intervention Description
    Prilosec® 40 mg
    Primary Outcome Measure Information:
    Title
    Bioequivalence based on Cmax and AUC parameters
    Time Frame
    4 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manoj K Bose, Dr.
    Organizational Affiliation
    Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs