Activities of cytochrome P-450 enzymes Not Applicable
Conditions
Interventions
Silexan (WS® 1265) 160 mg soft gelatine capsule or placebo for 11 days each. There is a screening visit within 14 days before the first intake of study drug
11 days of treatment (cross-over period 1)
a wash out period of 3 weeks
11 days treatment (cross-over period 2)
and a follow up visit within 4 - 10 days after last intake of study drug.
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and capable to confirm written consent 2. Caucasian male or female 3. Aged between 18 - 55 years 4. A body mass index (BMI) 19 - 29 kg/m^2 5. Healthy 6. Non-pregnant and non-lactating, and have a negative urine pregnancy test result if subject is female 7. Use reliable contraception, i.e. two methods simultaneously if subject is female and of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Subjects with any relevant clinical abnormality 2. Subjects with a tendency to loose stools and/or subjects with the history of a relevant surgical abdominal intervention 3. Subjects with any cardiac arrhythmia, subjects with acute infections within the last two weeks 4. Subjects with a history of any allergic disease with clinical signs 5. Subjects with suspicion of hypersensitivity to the investigational medication 6. Subjects with a history of severe skin reactions 7. Subjects receiving any medication within 2 weeks prior to study start or during the study 8. Subjects who have taken a drug with a long half-life (greater than 24 hours) within four weeks before the first trial day 9. Subjects who received chronic drug treatment (greater than 3 days) within eight weeks before the first trial day 10. Subjects who donated blood within the last 4 weeks before the start of the present study 11. Actual smokers defined as subjects who smoked any cigarette during the last three months 12. Subjects who are known or suspected to be (social) drug dependent 13. Subjects with a history of alcohol or recreational drug addiction 14. Subjects with positive drug screening tests 15. Subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods, and grapefruit flesh/juice from 1 week prior to the study until the safety follow-up examination 16. Anticipated problems of successfully placing an indwelling venous catheter at both forearms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CYP1A2 as quantified using AUC0-t of caffeine in plasma 2. CYP2C9 as quantified using AUC0-t of tolbutamide in plasma 3. CYP2C19 as quantified using AUC0-t of omeprazole in plasma 4. CYP2D6 as quantified using AUC0-t of dextromethorphan in plasma 5. CYP3A4 as quantified using AUC0-t of midazolam in plasma All measured on day 11 to day 12: 17 blood collections from 0 - 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic parameters of the phenotyping substances 2. Safety parameters All measured on day 11 to day 12: 17 blood collections from 0 - 24 hours. | — |
Countries
Germany
Outcome results
None listed