Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

Bioequivalence Study Clinical Trial

Official title:

A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765944
• Other study ID #: NPC-12T-1
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2018
• Est. completion date: December 29, 2018

Study information

• Verified date: February 2019
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Japanese healthy subjects aged 20 to 39 years of age

2. Subjects with BMI = 18.5 kg/m2 and < 25.0 kg/m2

3. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening

4. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration

5. Subjects who write informed consent

6. Subjects who are able to comply with the study requirements during the study period

Exclusion Criteria:

1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative

2. Subjects who have a history of hypersensitivity or allergies to other drug

3. SUbjects who have an acute or chronic infectious diseases

4. 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

5. Subjects who have diagnosed with alcoholism or a history of alcoholism

6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening

7. Subjects who have been administered other investigational drug within 12 weeks before the initial administration

8. 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

9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis

10. Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration

11. 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

12. Subjects who cannot speak, read and write in Japanese

13. Subjects who are considered by the investigator as unsuitable for participation in the trial

Related Conditions & MeSH terms

• Bioequivalence Study

Intervention

Drug:
• sirolimus
SIngle administration under fasted condition

Locations

Country	Name	City	State
Japan	Clinique Soigner	Matsudo	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood sirolimus concentration	Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.	Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)