geen van alle: Dit is veiligheidsonderzoek Absorption internal exposure
Conditions
Interventions
Intervention:
A single typical hair removal procedure per subject under controlled conditions
will be performed by trained personnel.
Sponsors
L'Oréal Worldwide Safety Evaluation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female; Age 18-45 years; Healthy as assessed by health questionnaire, physical examination and clinical chemistry (fasting state) Willing to refrain from blood donation during the whole study Willing to use adequate measures to avoid pregnancy during the whole study Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data Willing to refrain from hair removal (2 weeks) prior to day 01 of the study, either by mechanical or chemical means Avoiding using soap or products containing alcohol 24 hours before and after day 01 of the study. Avoiding prolonged sun exposure before and after the study.
Exclusion criteria
Exclusion criteria: Participation in any clinical trial including blood sampling and/or adminis¬tration of substances up to 90 days before Day 01 of this study Participation in any clinical trial or medical treatment including administration of a radiolabelled test substance up to 1 year before Day 01 of this study Having a history of metabolic or endocrine diseases Positive pregnancy test (urine) Prescribed medication (except oral contraceptives and paracetamol) Alcohol consumption more than 14 units/week (females) (1 unit of alcohol equals 10 grams of ethanol) Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The individual concentration of [14C]-radioactivity (recoveries) in all non-biological samples will be established and expressed as percentages relative to the applied dose. For biological samples (blood, faeces and urinary), the individual concentration versus time courses of [14C]-radioactivity will be established and expressed as percentages relative to the applied dose; results will also be expressed as [14C]-TGAeq or as [14C]-TGAeq per unit of mass (g) or volume (mL). | — |
Secondary
| Measure | Time frame |
|---|---|
| A Mass balance will be established | — |
Countries
Netherlands
Outcome results
None listed