Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study

NCT01654705 | Completed

• 1 other identifier: 223_PANTO_09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting conditions.condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Composite of Pharmacokinetics

  Cmax, Area Under Curve and Tmax

  Predose and at 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 4.75, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hour post dose in each period

Study Arms (2)

Pantoprazole Sodium Delayed release tablets

EXPERIMENTAL

Pantoprazole Sodium Delayed release tablets USP 40 mg of OHM Laboratories Inc.,USA

Drug: Pantoprazole

Protonix® Delayed Release 40 mg tablets

ACTIVE COMPARATOR

Protonix® Delayed Release 40 mg tablets of Wyeth Pharmaceuticals Inc.USA

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Pantoprazole 40mg Delayed release tablets (Test Product)

Pantoprazole Sodium Delayed release tablets

Eligibility Criteria

• Age: 19 Years - 43 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers who met the following criteria were included in the study
• Were in the age range of 18-45 years.
• Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Had voluntarily given written informed consent to participate in this study.
• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
• There were no deviations in this regard.

You may not qualify if:

• History of known hypersensitivity to Pantoprazole, related drugs and/or any other drugs.
• Use of alcohol within 48 hours prior to admission.
• Use of grapefruit juice and or grape fruit supplements within 48 hours prior to admission.
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Subjects with investigations (laboratory test parameters) which was/were outside acceptable limits and was judged clinically significant by investigator.
• Subjects with clinically abnormal ECG or Chest X-ray.
• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• Subjects with clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4 /HPF), glucose (Positive) or Protein (Positive).
• History of serious medical illness including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma, any serious potentially life threatening illness or any psychiatric illness (which might impair the ability to provide written informed consent form).
• Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
• History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
• Use of any regular medication (OTC or prescription) or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study.
• Participation in any clinical trial within 12 weeks preceding Day 1 of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I dosing).
• Subjects who, through completion of this study, would have donated and /or lost more than 350 ml of blood in the past 3 months other than study participation.
• Subjects with problem(s) in complying with the study protocol.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, 201301, India

Location

Related Links

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MeSH Terms

Interventions

Pantoprazole

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: August 1, 2012
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-06

Locations

IN (1)