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

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.

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.

Study Overview

• Status: Completed
• Conditions: FED
• Intervention / Treatment: Drug: Pantoprazole Sodium

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
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhrapradesh
    • Hyderabad, Andhrapradesh, India, 500 051
      • VimtaLabsLtd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Protonix DR Tablets 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence on Cmax and AUC parameters	2 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Mangesh Kulkarni, M.D, VimtaLabsLtd.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2011
• Last Update Submitted That Met QC Criteria: January 25, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: PAN/23/88/04-05