Healthy people
Conditions
Interventions
group ?:The first period of oral test preparation on an empty stomach, the elution period is 5 days, the second period of oral reference preparation on an empty stomach, the elution period is 5 days,
group ?:The first period of oral reference preparation on an empty stomach, with an elution period of 5 days, the second period of oral test preparation on an empty stomach, with an elution period of
group ?:The first period of oral reference preparation on an empty stomach, with an elution period of 5 days, the second period of oral reference preparation on an empty stomach, with an elution perio
Sponsors
Yue Bei People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy male or female Chinese adults, aged 18 or older (2)Body mass indexes (BMIs) ranging from 19 to 26 kg/m2, and weights higher than 50kg (3)Willing to participate the trial and signed informed consent forms
Exclusion criteria
Exclusion criteria: (1)smoke more than five cigarettes per day (2)had history or condition of severe hepatic, cardiovascular, gastrointestinal, renal disease or any disease that could interferes with the results of the test (3)had condition of biliary obstructive disorders (4)A history of allergy to drugs, foods, or other substances or hypertensive to Mycophenolate Sodium, Mycophenolic acid, Mycophenolate mofetil or any excipient included (5)drug abuse within 12 months prior to screening (6)had received any other medication within fourteen days prior to the start of study (7)participated in any clinical study within 3 months prior to the screening (8)donation or loss more than 400 mL of blood within 3 months prior to the screening (9)take other medicines or food supplementary or vitamins within 14 days before first study drug administration (10) alcohol breath test or drug abuse screening positive (11) used any strong CYP3A4 inhibitor, strong CYP3A4 inducer, or drug that interacted with the study drug within 30 days before taking the study drug for the first time and who were judged by the investigators to be unfit to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;Serious adverse events; | — |
Countries
China
Contacts
Public ContactWenmao Fan
Yue Bei People's Hospital
Outcome results
None listed