Drug Interaction Study Clinical Trial
Official title:
Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers
Verified date | March 2018 |
Source | Max Zeller Soehne AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | June 23, 2018 |
Est. primary completion date | May 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Nuvisan GmbH | Neu-Ulm |
Lead Sponsor | Collaborator |
---|---|
Max Zeller Soehne AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the Plasma concentration versus time curve (AUC0-t) | Pharmacokinetic Parameter AUC0-t (mg*h/L) of the probe drugs will be determined. | 72 hours | |
Secondary | Area under the Plasma concentration versus time curve (AUC0-inf) | Pharmacokinetic parameter (mg*h/L) of the probe drugs and their metabolites will be determined. | 72 hours | |
Secondary | Peak Plasma Concentration (Cmax) | Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined. | 72 hours | |
Secondary | Elimination rate constant (Ke) | Pharmacokinetic Parameter (h^-1) of the probe drugs and their metabolites will be determined. | 72 hours | |
Secondary | Elimination half life (t1/2) | Pharmacokinetic Parameter (h) of the probe drugs and their metabolites will be determined. | 72 hours |
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