Healthy volunteers
Conditions
Interventions
Single intake of test supplement A (standardized unformulated curcumin extract), dose as curcumin:260.2 mg
Single intake of test supplement B (solid lipid curcumin particle formulation), dose as curcu
Sponsors
Lequio Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese healthy males and females aged 20-65 years (age is the date of consent acquisition). 2) Subjects who weigh 50 kg or more for male and 45 kg or more for female. 3) Subjects who agree to participate in this study and can sign and date the consent document by themselves.
Exclusion criteria
Exclusion criteria: 1) Subjects with disorders of central nervous system, cardio-vascular system, respiratory system, blood/hematopoietic function system, gastrointestinal system, liver/renal function, thyroid function, pituitary function, adrenal function, etc. or having a medical history of these disorders, and judged by the investigator to have safety concerns to conduct the study. 2) Subjects with a history of gastrointestinal symptoms or gastrointestinal resection that affect pharmacokinetics. 3) Subjects who are taking pharmaceuticals or undergoing therapy. 4) Subjects with drug allergies or history. 5) Subjects with allergic to curcumin-containing foods. 6) Subjects who have felt sick during blood donation and blood collection. 7) Subjects who have collected more than 400 mL of blood (such as blood donation) within the past 90 days starting from the scheduled administration date, or those who have collected more than 1200 mL of blood annually, including the blood collected in this study. 8) Subjects who cannot maintain abstinence and smoking cessation from 3 days before to the end of the study starting from the scheduled administration date. 9) Subjects who received other investigational drug within the past 90 days starting from the scheduled administration date. 10) Subjects who have taken supplements containing curcumin within the past 14 days starting from the scheduled administration date. 11) Subjects who have ingested curcumin-containing foods such as curry within the past 7 days starting from the scheduled administration date. 12) Employees of the implementing medical institution and employees of the study consignment organization. 13) Female subjects who wish to become pregnant during the study period, pregnant women (including possible) or breastfeeding. 14) In addition, subjects who are judged to be ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma curcuminoids (curcumin, demethoxycurcumin, bisdemethoxycurcumin) concentration after a single ingestion of a curcumin-containing supplement. | — |
Countries
Japan
Contacts
Public ContactKoji Teshima
Lequio Pharma Co., Ltd. Research & Development Headquarters
Outcome results
None listed