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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01513057
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Mycophenolate Mofetil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Cellcept
Cellcept 250 mg capsules of Roche Laboratories Inc.
Drug: Mycophenolate Mofetil
250 mg capsules of Roche Laboratories Inc.
Other Name: Cellcept

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513057

Locations
India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, India, 3 80 061
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Pankaj Kumar Jha, MD LAMBDA THERAPEUTIC RESEARCH LTD
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01513057     History of Changes
Other Study ID Numbers: 466-08
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
bioequivalence
Mycophenolate Mofetil
crossover

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014