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

NCT01283919 | Completed Phase 1

• 1 other identifier: PAN/23/87/04-05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence on Cmax and AUC parameters

  2 months

Study Arms (2)

Pantoprazole Sodium

EXPERIMENTAL

Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited

Drug: Pantoprazole Sodium

Protonix

ACTIVE COMPARATOR

Protonix 40 mg DR Tablets of Wyeth Laboratories

Drug: Pantoprazole Sodium

Interventions

Pantoprazole Sodium DRUG

Pantoprazole Sodium DR Tablets 40 mg

Also known as: Protonix DR Tablets 40 mg

Pantoprazole Sodium; Protonix

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will provide written informed consent.
• Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
• 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.
• 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.
• Have normal EcG, X-ray and vital signs.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If subject is a female volunteer and
• 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.
• is postmenopausal for at least 1 year.
• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

You may not qualify if:

• Subjects incapable of understanding the informed consent.
• Subjects with BP≤90/60 or BP≥140/90
• History of hypersensitivity or idiosyncratic reaction to pantoprazole or other proton pump inhibitors.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
• 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.
• History of any psychiatric illness, which may impair the ability to provide written, informed consent.
• Subjects who have a history of alcohol or substance abuse within the last 5 years.
• Subjects with clinically significant abnormal values of laboratory parameters.
• Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• Subjects with positive urine screen for drugs of abuse.
• Any subject in whom pantoprazole is contraindicated for medical reasons.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breast-feeding.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

VimtaLabsLtd.

Hyderabad, Andhrapradesh, 500 051, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mangesh Kulkarni, M.D

  VimtaLabsLtd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: October 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: January 26, 2011

Record last verified: 2011-01

Locations

IN (1)