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Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01418417
First received: August 10, 2011
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

Objective:

To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7 days.

Study Design:

randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects


Condition Intervention Phase
Healthy
Drug: Torrent's Pantoprazole Sodium Delayed - Release Tablets
Phase 1

Study Type: Interventional
Official Title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets of Torrent Pharmaceutical Limited., India and Protonix® (Pantoprazole Sodium) 40 mg Delayed Release Tablets of Wyeth Pharmaceuticals Inc, in Healthy Human Adult Subjects, Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax parameter [ Designated as safety issue: No ]
    bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for Cmax

  • Bioequivalence based AUC parameter
    bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUC(o-t).


  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy human adult subjects between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
  • Subjects who have no evidence of underlying disease during screening history and whose physical examination is performed within 21 days prior to commencement of the study.
  • Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
  • Informed consent given in written form according to section 11.3 of the protocol.
  • Female Subjects:

    1. 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. Postmenopausal for at least 1 year.
    3. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

  • History or presence of significant:

    1. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
    2. Alcohol dependence, alcohol abuse or drug abuse within past one year.
    3. Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
    4. History of difficulty in swallowing tablet / capsule.
    5. Clinically significant illness within 4 weeks before the start of the study
    6. Asthma, urticaria or other allergic type reactions after taking any medication.
    7. Positive urine drug screening, HIV, Hepatitis B & C tests.
    8. Any history of hypersensitivity to Pantoprazole Sodium.
    9. Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
    10. Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development / impaired cerebral function.
  • Subject who has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks prior to the start of the study.
  • Subjects who have:

    1. Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg.
    2. Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. 3) Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.

    4) Pulse rate below 50/minute or above 105/minute.

  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: NCT01418417

Locations
India
Lotus Labs Pvt. Ltd.
Bangalore,, Karnataka,, India
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

Responsible Party: Chief Investigator, Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01418417     History of Changes
Other Study ID Numbers: 1200/07
Study First Received: August 10, 2011
Last Updated: August 15, 2011
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014