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

NCT01418417 | Completed Phase 1

• 1 other identifier: 1200/07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax 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 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).

Interventions

Torrent's Pantoprazole Sodium Delayed - Release Tablets DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History or presence of significant:
• Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
• Alcohol dependence, alcohol abuse or drug abuse within past one year.
• Moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products.
• History of difficulty in swallowing tablet / capsule.
• Clinically significant illness within 4 weeks before the start of the study
• Asthma, urticaria or other allergic type reactions after taking any medication.
• Positive urine drug screening, HIV, Hepatitis B \& C tests.
• Any history of hypersensitivity to Pantoprazole Sodium.
• 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.
• 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:
• Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg.
• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Lotus Labs Pvt. Ltd.

Bangalore, Karnataka, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 17, 2011
• Last Updated: August 17, 2011

Record last verified: 2011-08

Locations

IN (1)