Bioequivalence of mycophenolate mofetil in healthy volunteers. Mycophenolate Mofetil Bioequivalence study, Healthy
Conditions
Interventions
Each capsule contains 250 mg mycophenolate mofetil.,Each capsule contains 250 mg mycophenolate mofetil.
Experimental Drug,Active Comparator Drug
Generic mycophenolate mofetil 250 mg capsules,Mycophenolate mofetil 250 mg capsules, CELLCEPT
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male subjects between the ages of 18 to 55 years. 2.Body mass index between 18.5 to 30.0 kg/m2. 3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4.Male subjects who are not wishing to be a father of a child during the study or who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 14 days after the end of study in Period 2. 5.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to mycophenolate mofetil or mycophenolic acid or to any of the excipients. 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. 3. History or evidence of organ transplant. 4. History or evidence of lupus nephritis. 5. History or evidence of leukopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anaemia. 6. History or evidence of gout or Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome. 7. History about administration of vaccine within 30 days prior to check-in in each Period. 8. History of febrile illness within 7 days prior to check-in in each period. 9. History of problems with swallowing tablet or capsule. 10.History of sensitivity to heparin or heparin-induced thrombocytopenia. 11.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. 12.History of diarrhea or vomiting within 24 hours prior to check-in in each period. 13.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). 14.Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subjects eligibility. 15.Investigation with blood sample shows positive test for HBsAg. 16.Abnormal liver function, is greater than or equal to1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. 17.Have eGFR (CKD-EPI) < 90 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment. 18.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. 19.History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening i.e., alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.). 20.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result. In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-tlast and AUC0-inf will be determined from the plasma concentration data of analytes. 0-72 hours post dose Mass spectrometry (LC-MS/MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of the maximum plasma concentration (Tmax) , The elimination half-life (t1/2) and lambdaz will be determined from the plasma concentration data of analytes. 0-72 hours post dose Mass spectrometry (LC-MS/MS) | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed