Healthy subjects
Conditions
Interventions
Group 1: Curcumin-formulation, oral, 200 mg/day, single dose
Group 2: Curcumin powder, oral, 200 mg/day, single dose
Group 3: Curcumin (lecithin formulation) or curcumin (polysorbate formulation), ora
Sponsors
Apomedica Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Healthy men and women - BMI: 19 - 30 kg/m2 - Non-smoker - Written consent to participate in the study - Able and willing to follow the study procedure
Exclusion criteria
Exclusion criteria: Main exclusion criteria: - Relevant history or presence of any severe medical disorder, potentially interfering with this study - Known allergy and hypersensitivity to ingredients of the study product - Blood donation within 1 month prior to study start or during study - Significant changes in lifestyle or medication (within last 3 months) or surgical intervention or surgical procedure such as bariatric surgery - For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening - “Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men - Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during the study (e.g. curcumin) - Chronic intake of substances affecting blood coagulation, which in the investigator’s opinion would impact subject safety - Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study. - Known pregnancy, breast feeding or intention to become pregnant during the study. - Anticipating any planned changes in lifestyle for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From concentration-time curve of total curcuminoids over a time period of 0-8h the area under the curve will be determined. Comparison of AUC between study products. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Cmax and Tmax between study products. | — |
Countries
Germany
Contacts
Public ContactTanja Wagner
BioTeSys GmbH
Outcome results
None listed