- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00908128
Mycophenolate Mofetil Tablets Under Fed Conditions
A Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M1R 5A3
- Pharma Medica Research Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy, non-smoking male subjects, 18 years of age or older.
- Healthy, non-smoking post-menopausal or surgically sterile females 18 years of age or older.
- BMI ≥ 19 and ≤ 30.
Negative for:
- HIV.
- Hepatitis B surface antigen and Hepatitis C antibody.
- Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- Urine cotinine test
- Serum HCG consistent with pregnancy (females only)
- No significant diseases or clinically significant findings in a physical examination.
- No clinically significant abnormal laboratory values.
- No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
- Be informed of the nature of the study and given written consent prior to receiving any study procedure.
Females who participate in this study must be unable to have children:
post-menopausal for at least 1 year - no menstrual cycle for 12 months and LH and FSH levels judged by a physician to be consistent with post-menopausal status.
OR
- Proof of surgical sterility.
- Females who participate in this study are not pregnant and/or non-lactating.
Exclusion Criteria:
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- Known or suspected increased susceptibility to infection.
- Known history or presence of active tuberculosis (TB).
- Results of a previous TB skin test greater than 5 mm in diameter.
- Lived in or traveled, during the last 8 weeks, to a country defined by the Public Health Agency of Canada as having WHO estimated sputum smear positive pulmonary TB rate of 15 per 100,000 or higher.
Known history or presence of:
- Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any other drug substances with similar activity.
- Alcoholism within the last 12 months.
- Drug dependence and/or substance abuse.
- Use of tobacco or nicotine-containing products within the last 6 months.
- On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
- Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
- Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
- Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
- Difficulty fasting or consuming the standard meals.
- Do not tolerate venipuncture.
- Unable to read or sign the ICF.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mycophenolate Mofetil (test) First
Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
|
Mycophenolate Mofetil 500 mg Tablet
|
Active Comparator: CellCept® (reference) First
CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
|
CellCept® Tablets, 500 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 72 hour period
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 72 hour period
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration
Time Frame: Blood samples collected over 72 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 72 hour period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xueyu (Eric) Chen, MD, PhD., FRCP(C), Pharma Medica Research, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-1264
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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