Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
Subjects who have a history of hypersensitivity or allergies to other drug
SUbjects who have an acute or chronic infectious diseases
Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
Subjects who have diagnosed with alcoholism or a history of alcoholism
Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
Subjects who have been administered other investigational drug within 12 weeks before the initial administration
Subjects who have performed blood collection or donation as follows
Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
Subjects who cannot speak, read and write in Japanese
Subjects who are considered by the investigator as unsuitable for participation in the trial
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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