Bioequivalence Study of NPC-12 (Sirolim… | Clinical Trial

Key information

Conditions

Bioequivalence Study

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinique Soigner

Matsudo, Chiba, 270 -2231, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 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

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

Treatment and study plan

sirolimus

Drug

SIngle administration under fasted condition

Primary outcomes

Blood sirolimus concentration

Time frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)

Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Dec 5, 2018
Registry last updated: Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed