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

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. Identifier: NCT01283932
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : January 26, 2011
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:
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 or disease Intervention/treatment Phase
FED Drug: Pantoprazole Sodium Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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 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.
Study Start Date : October 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bioequivalence on Cmax and AUC parameters [ Time Frame: 2 months ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01283932

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

Responsible Party: Vice President-Research and Development, Dr. Reddy's Laboratories Limited Identifier: NCT01283932     History of Changes
Other Study ID Numbers: PAN/23/88/04-05
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

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