Metabolic drug interaction profile of Silexan in vivo

Completed

• Conditions: Activities of cytochrome P-450 enzymes; Not Applicable

• Registration Number: ISRCTN74386009
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified