Absorption and kinetics of P15 oil after single oral administration of P15 oil in human volunteers

Absorption and kinetics of P15 oil after single oral administration of P15 oil in human volunteers - Absorption and kinetics of P15 oil

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34142

Enrollment

Registered

2010-09-20

Start date

2010-10-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen geen

Interventions

One single controlled oral dose of P15 oil will be given, followed by blood sampling at pre-determined time points up to 168 hours post administration.Assuming a mean bodyweight of 70 kg, the actual

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Healthy as assessed by the TNO health and lifestyle questionnaire 2.Females aged between 18-35 years at Day 01 of the study 3.Body weight between 55 and 85 kilograms 4.Voluntary participation 5.Having given written informed consent 6.Willing to comply with the study procedures , including stop using specified cosmetics and food products 7.Appropriate veins for blood sampling according to TNO 8.Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years 9.Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion criteria

Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances 3. Having a history of medical or or endocrine diseases or surgical events that may significantly affect the study outcome 4. Prescribed medication (except paracetamol occasionally) 5. Smoking 6. Using cosmetics, including bodylotion, baby oils, lipstick or pomade (other restrictions to be discussed), or not willing to stop using these products before and during the study period 7. Alcohol consumption > 21 units/week 8. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening 9. Recent blood donation (

Design outcomes

Primary

Measure	Time frame
The main study parameter is the blood kinetics (Cmax, AUC) of P15H oil after single consumption.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)