Status:
COMPLETED
Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets
Lead Sponsor:
Nobelpharma
Conditions:
Bioequivalence Study
Eligibility:
All Genders
20-39 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
Eligibility Criteria
Inclusion
- Japanese healthy subjects aged 20 to 39 years of age
- Subjects with BMI ≥ 18.5 kg/m2 and \< 25.0 kg/m2
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
- Subjects who write informed consent
- Subjects who are able to comply with the study requirements during the study period
Exclusion
- 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
- Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
- Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
- Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
- Collected or donated blood component within 2 weeks before the initial administration
- 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
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03765944
Start Date
December 5 2018
End Date
December 29 2018
Last Update
February 25 2019
Active Locations (1)
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1
Clinique Soigner
Matsudo, Chiba, Japan, 270 -2231