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Trial record 46 of 1167 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT01513044
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE January 16, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date January 20, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions
Official Title  ICMJE 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.
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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 Name: Cellcept
Study Arms  ICMJE
  • Experimental: Mycophenolate Mofetil
    Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Mycophenolate Mofetil
  • Active Comparator: Cellcept
    Cellcept 250 mg capsules of Roche Laboratories Inc.
    Intervention: Drug: Mycophenolate Mofetil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2012)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513044
Other Study ID Numbers  ICMJE 08-VIN-182
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinesh Shah, MD veeda clinical research Pvt. Ltd
PRS Account Dr. Reddy's Laboratories Limited
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP