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

NCT03765944 | Completed Phase 1

• 1 other identifier: NPC-12T-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Bioequivalence Study

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

NPC-12 granule

ACTIVE COMPARATOR

NPC-12 granules (1.0g: 2mg sirolimus)

Drug: sirolimus

NPC-12T tablet

ACTIVE COMPARATOR

NPC-12T 2 tablets (2mg sirolimus)

Drug: sirolimus

Interventions

sirolimus DRUG

SIngle administration under fasted condition

NPC-12 granule; NPC-12T tablet

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

Clinique Soigner

Matsudo, Chiba, 270 -2231, Japan

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: December 5, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)