Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01283841
First received: January 24, 2011
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Fasting
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, Four-period, Two Sequence, Single Dose, Replicate, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg tablets of Dr. Reddy's Laboratories Limited
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg tablets
Other Name: Cellcept
Active Comparator: Cellcept
Cellcept 500 mg tablets of Roche Laboratories Inc.
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg tablets
Other Name: Cellcept

Detailed Description:

This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 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 three hours after dosing.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.
  2. 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.
  3. 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.
  4. Able to comply with the study procedures, in the opinion of the Principal Investigator.
  5. Able to give written consent for participation in the trial.

Exclusion Criteria:

  1. Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any drug.
  2. Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
  3. 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.
  4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
  5. 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.
  6. Smokers, who had a habit of smoking 10 or more than 10 cigarettes / day or could, not abstain from smoking during the study.
  7. The presence of clinically significant abnormal laboratory values during screening.
  8. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug scan.
  9. History of psychiatric disorders.
  10. A history of difficulty with donating blood.
  11. 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.

  12. A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies.
  13. A positive test result for HIV antibody and / or syphilis.
  14. The 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 medication. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.

    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.

  15. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subject's participation in the study. In any such case selection of the subject will be at the discretion of the Principal Investigator/Medical Expert.
  16. Uric acid parameters at the time of screening are not within clinically acceptable range.
  17. History of gout and renal calculi.
  18. Sitting blood pressure less than 100/60 mm Hg at the time of screening.
  19. Haemoglobin less than 13 gm/dL at the time of screening.
  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: NCT01283841

Locations
India
Lambda Therapeutic Research Ltd
Bodakdev, Ahmedabad, India, 3 80 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: T Gitanjali, MD LAMBDA THERAPEUTIC RESEARCH LTD
  More Information

No publications provided

Responsible Party: Director-Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01283841     History of Changes
Other Study ID Numbers: 291-07
Study First Received: January 24, 2011
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014