Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions

NCT01283841 | Completed Phase 1

• 1 other identifier: 291-07
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence on Cmax and AUC parameters

  3 months

Study Arms (2)

Mycophenolate Mofetil

EXPERIMENTAL

Mycophenolate Mofetil 500 mg tablets of Dr. Reddy's Laboratories Limited

Drug: Mycophenolate Mofetil

Cellcept

ACTIVE COMPARATOR

Cellcept 500 mg tablets of Roche Laboratories Inc.

Drug: Mycophenolate Mofetil

Interventions

Mycophenolate Mofetil DRUG

Mycophenolate Mofetil 500 mg tablets

Also known as: Cellcept

Cellcept; Mycophenolate Mofetil

Eligibility Criteria

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

You may qualify if:

• Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.
• Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2.
• Having no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (postero-anterior view) recordings.
• Able to comply with the study procedures, in the opinion of the Principal Investigator.
• Able to give written consent for participation in the trial.

You may not qualify if:

• Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any drug.
• Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
• Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator /Medical Expert.
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
• A recent history of alcoholism (\<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hours of receiving study medicine.
• Smokers, who had a habit of smoking 10 or more than 10 cigarettes / day or could, not abstain from smoking during the study.
• The presence of clinically significant abnormal laboratory values during screening.
• Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug scan.
• History of psychiatric disorders.
• A history of difficulty with donating blood.
• Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of the study medicine or during the study.
• Note: In case the blood loss was ≤ 200 mL, the subject was enrolled 60 days after blood donation.
• A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies.
• A positive test result for HIV antibody and / or syphilis.
• Note: If the subject had participated in a study in which blood loss was ≤ 200 mL, the subject was dosed 60 days after the collection of last sample in the previous study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd

Bodakdev, Ahmedabad, 3 80 054, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• T Gitanjali, MD

  Lambda Therapeutic Research Ltd.

  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 24, 2011
• First Posted: January 26, 2011
• Study Start: November 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 26, 2011

Record last verified: 2011-01

Locations

IN (1)