Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed Conditions

An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fed Conditions.

An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Mycophenolate Mofetil; Drug: Mycophenolate Mofetil

Detailed Description

This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under fed conditions.64 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first two hours after dosing.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 3 80 061
      • Lambda Therapeutic Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, adult, human male volunteers between 18 - 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
• Having a Body Mass Index (BMI) between 18.5 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.
• Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest recordings.
• Able to comply with the study procedures, in the opinion of the Principal investigator.
• Able to give voluntary written informed consent for participation in the study.

Exclusion Criteria:

• Known hypersensitivity or idiosyncratic reaction to Mycophenolate mofetil or any related drug.
• Any disease or condition that compromised 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 was at the discretion of the Principal Investigator.
• 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 prior to receiving study medicine.
• Smokers, who smoked 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
• Consumption of Grapefruits or its products within a period of 48 hours prior to dosing.
• 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 drug scans.
• History of psychiatric disorders.
• A history of difficulty with donating blood.
• Donation of blood (1 unit or 350 mL) or receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medicine. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.

Note: If subject had participated in a study in which blood loss was ≤ 200 mL, subject could be enrolled 60 days after the last sample of previous study.

• A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
• A positive test result for HIV antibody and/or syphilis.
• An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subjects' participation in the study. In any such case subject selection was at the discretion of the Principal Investigator.

All the enrolled subjects satisfied all the above inclusion and exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mycophenolate Mofetil; Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited	Drug: Mycophenolate Mofetil; Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited; Drug: Mycophenolate Mofetil; 250 mg capsules of Roche Laboratories Inc.; Other Names: Cellcept
Active Comparator: Cellcept; Cellcept 250 mg capsules of Roche Laboratories Inc.	Drug: Mycophenolate Mofetil; Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited; Drug: Mycophenolate Mofetil; 250 mg capsules of Roche Laboratories Inc.; Other Names: Cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve (AUC)	pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Pankaj Kumar Jha, MD, Lambda Therapeutic Research Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 16, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2012
• Last Update Submitted That Met QC Criteria: January 19, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: bioequivalence; Mycophenolate Mofetil; crossover
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: 466-08