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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01513044
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 fasting 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 Fasting 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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2009
Study Completion Date: January 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 Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 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 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged between 18 and 50 years (including both).
  • Subjects' weight within the normal range according to normal values for the Body
  • Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  • Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  • Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
  • Subjects having clinically acceptable chest X-Ray (PIA view).
  • Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  • Subjects having negative alcohol breath test.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

The subjects were excluded from the study, if they meet any of the following criteria:

  • Hypersensitivity to Mycophenolate Mofetil or related drugs.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • History or presence of significant alcoholism or drug abuse in the past one year.
  • History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
  • History or presence of asthma, urticaria or other significant allergic reactions.
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  • History or presence of cancer.
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • Donation of blood in the past 3 months before screening.
  • Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
  • History or presence of significant easy bruising or bleeding.
  • History or presence of significant recent trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513044

Locations
India
veeda clinical research Pvt. Ltd
Ahmedabad, Gujarat, India, 3 80 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Jinesh Shah, MD veeda clinical research Pvt. Ltd
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01513044     History of Changes
Other Study ID Numbers: 08-VIN-182
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:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014