Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition

NCT01603134 | Completed Phase 1 DMC

• 1 other identifier: Ipca/US/07/030
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting State

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Allopurinol 300 mg Tablets USP

EXPERIMENTAL

Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India

Drug: Allopurinol

Zyloprim®

ACTIVE COMPARATOR

Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA,

Drug: Allopurinol

Interventions

Allopurinol DRUG

300 mg tablet once a day

Also known as: Test Product

Allopurinol 300 mg Tablets USP

Eligibility Criteria

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

You may qualify if:

• Male subjects in the range of 18 - 45 years of age (Inclusive).
• 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.
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
• Subjects with normal findings, as determined by hematological tests, serum biochemistry, urine analysis, ECG and X-ray (if required).
• Willingness to follow the protocol requirements as evidenced by written informed consent.
• 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.
• No history or presence of significant alcoholism in the past one year.
• 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.

You may not qualify if:

• Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1) of dosing.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Subjects with history of recent myocardial infraction, cardiac arrhythmias, cardiac failure and convulsions.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• 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.
• 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.
• Any contraindication with blood sampling.
• Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until the last sample collection of each period.
• Found positive in breath alcohol test done at the time of check-in for each study period.
• History of drug abuse in past one year.
• Use of xanthine-containing beverages or food, and fruit juice or grapefruit juice products for 48.00 hours prior to each drug dose.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HBsAg or Hepatitis-C, HIV tests and anti Treponema Palladium/Syphilis test.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Accutest Research Lab (I) Pvt. Ltd.

Ahmedabad, Gujarat, India

Location

MeSH Terms

Interventions

Allopurinol

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Nirav Gandhi, M.D.

  Accutest Research Lab (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

IN (1)