Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition

A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Comparative Bioequivalence Study of Allopurinol 300 mg Tablets USP With Zyloprim® 300 mg in Normal, Healthy, Adult, Human Male Subjects Under Fasting Condition.

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.

Study Overview

• Status: Completed
• Conditions: Fasting State
• Intervention / Treatment: Drug: Allopurinol

Detailed Description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy, adult, human male subjects in a randomized crossover study.

The study was conducted with 32 healthy adult male subjects. In each study period, a single 300 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was 51 days including washout period of at 18 days between administrations of study drug in each study period.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India
      • Accutest Research Lab (I) Pvt. Ltd.

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. Male subjects in the range of 18 - 45 years of age (Inclusive).
2. The healthy human male subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
4. Subjects with normal findings, as determined by hematological tests, serum biochemistry, urine analysis, ECG and X-ray (if required).
5. Willingness to follow the protocol requirements as evidenced by written informed consent.
6. Agreeing to, not using any medication(either prescribed, OTC or alternate medicines), including vitamins and minerals for 14 days prior to study and during the course of the study.
7. No history or presence of significant alcoholism in the past one year.
8. Non-smokers, ex-smokers and light smokers will be included. "Light smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers as someone who completely stopped smoking for at least 3 months.

Exclusion Criteria:

1. Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1) of dosing.
2. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
3. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
4. Subjects with history of recent myocardial infraction, cardiac arrhythmias, cardiac failure and convulsions.
5. Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
6. History of malignancy or other serious diseases.
7. Refusal to abstain from food for at least ten (10.00) hours prior to administration of study drug and for at least four (04.00) hours post-dose.
8. Refusal to abstain from water for at least one (01.00) hour prior to study drug administration of each study period and for at least two (02.00) hours post-dose except about 240 mL administered during administration dose.
9. Any contraindication with blood sampling.
10. Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until the last sample collection of each period.
11. Found positive in breath alcohol test done at the time of check-in for each study period.
12. History of drug abuse in past one year.
13. Use of xanthine-containing beverages or food, and fruit juice or grapefruit juice products for 48.00 hours prior to each drug dose.
14. Blood donation 90 days prior to the commencement of the study.
15. Subjects with positive HBsAg or Hepatitis-C, HIV tests and anti Treponema Palladium/Syphilis test.
16. History of hypersensitivity to Allopurinol or any ingredients of formulation.
17. History of problem in swallowing Tablet(s).

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: Allopurinol 300 mg Tablets USP; Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India	Drug: Allopurinol; 300 mg tablet once a day; Other Names: Zyloprim®
Active Comparator: Zyloprim®; Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA,	Drug: Allopurinol; 300 mg tablet once a day; Other Names: Zyloprim®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence is based on Cmax and AUC parameters.	Area Under Curve (AUC) and Cmax Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose.	6 months

Collaborators and Investigators

• Sponsor: IPCA Laboratories Ltd.
• Investigators: Principal Investigator: Dr. Nirav Gandhi, M.D., Accutest Research Lab (I) Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: May 18, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: Ipca/US/07/030