Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01283932
First received: January 25, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 52 (+ 6 standby) healthy, adult, human subjects under fasting conditions.


Condition Intervention Phase
FED
Drug: Pantoprazole Sodium
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 of Pantoprazole Sodium 40 mg Delayed Release Tablets (Dr. Reddy's Laboratories Ltd, India) to be Compared With Protonix® 40 mg (Pantoprazole Sodium) Delayed Release Tablets (Wyeth Laboratories, USA) in Healthy, Adult, Human Subjects Under Fed Conditions.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: October 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pantoprazole Sodium
Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited
Drug: Pantoprazole Sodium
Pantoprazole Sodium DR Tablets 40 mg
Other Name: Protonix DR Tablets 40 mg
Active Comparator: Protonix
Protonix 40 mg DR Tablets of Wyeth Laboratories
Drug: Pantoprazole Sodium
Pantoprazole Sodium DR Tablets 40 mg
Other Name: Protonix DR Tablets 40 mg

Detailed Description:

This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fed conditions.52 (+6 standby) healthy, adult, human subjects were enrolled. A single oral dose of 40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water within 30 minutes after serving a high fat breakfast.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will provide written informed consent.
  2. Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
  3. Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
  4. Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study.
  5. Have normal EcG, X-ray and vital signs.
  6. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  7. If subject is a female volunteer and

    1. Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
    2. is postmenopausal for at least 1 year.
    3. is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

  1. Subjects incapable of understanding the informed consent.
  2. Subjects with BP≤90/60 or BP≥140/90
  3. History of hypersensitivity or idiosyncratic reaction to pantoprazole or other proton pump inhibitors.
  4. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  5. Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
  6. Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical period.
  7. History of any psychiatric illness, which may impair the ability to provide written, informed consent.
  8. Subjects who have a history of alcohol or substance abuse within the last 5 years.
  9. Subjects with clinically significant abnormal values of laboratory parameters.
  10. Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
  11. Subjects with positive urine screen for drugs of abuse.
  12. Any subject in whom pantoprazole is contraindicated for medical reasons.
  13. Female volunteers demonstrating a positive pregnancy screen.
  14. Female volunteers who are currently breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283932

Locations
India
VimtaLabsLtd.
Hyderabad, Andhrapradesh, India, 500 051
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mangesh Kulkarni, M.D VimtaLabsLtd.
  More Information

No publications provided

Responsible Party: Vice President-Research and Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01283932     History of Changes
Other Study ID Numbers: PAN/23/88/04-05
Study First Received: January 25, 2011
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pantoprazole
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 August 01, 2014