Status:
UNKNOWN
Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117
Lead Sponsor:
Max Zeller Soehne AG
Conditions:
Drug Interaction Study
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.
Detailed Description
Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions. The study design is standard for DDI s...
Eligibility Criteria
Inclusion
- written informed consent
- Caucasian male or female subjects aged between ≥18 and ≤55years
- Physically and mentally healthy
- BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
- Non-smoker
- If female, the pregnancy test at screening and at admission must be negative
Exclusion
- Known or suspected hypersensitivity to study drugs
- history of, any clinically significant diseases
- Positive test of hepatitis B, hepatitis C or HIV Screening
- Known photohypersensitivity
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03482817
Start Date
February 5 2018
End Date
June 23 2018
Last Update
March 29 2018
Active Locations (1)
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1
Nuvisan GmbH
Neu-Ulm, Germany