Healthy
Conditions
Keywords
Pharmacokinetics
Brief summary
A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition.
Interventions
DRUGSt. John's wort prolonged-release tablet 500 mg
DRUGSt. John's wort film coated tablets 250 mg
Sponsors
Max Zeller Soehne AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Caucasian male volunteers * Physically and mentally healthy as judged by means of a medical and standard laboratory examination * BMI of between 19 and 29 kg/m2, inclusively * Weight not exceeding 90 kg * Non-smokers (confirmed by urine cotinine test) * Informed cConsent as documented by signature
Exclusion criteria
* Known or suspected hypersensitivity to any ingredient of the investigational medicinal product * Any clinically significant illnesses or clinically significant surgery within 1 year prior to the administration of the study medication * Any surgical or medical condition which might interfere with absorption, distribution, metabolism or excretion of the drug * Any clinically significant abnormality or abnormal laboratory test results, as judged by the investigator found during the medical screening * Positive test of hepatitis B, hepatitis C or HIV screening (HIV antibody, Hepatitis B (HBsAg), Hepatitis C (HCV) * ECG abnormalities (clinical significant) or vital signs abnormalities (systolic blood pressure lower than 90 or over 145 mmHg, diastolic blood pressure lower than 60 or over 95 mmHg, or heart rate less than 45 or over 100bpm) at screening * History of asthma or obstructive pulmonary disease (e.g.COPD) * Known photohypersensitivity. * Presents or history of alcohol dependence within the last year (\> 40 g ethanol/d or more than 10 units per weeks (1unit=150 ml of wine or 360 ml of beer or 45 ml alcohol 45%)) * History of drug dependence or positive results of drug screen * Concomitant participation in another clinical trial within the 4 weeks prior to the planned first drug administration. * Donation of blood or blood products within 30 days prior to the planned first drug administration. * Treatment with any medication or topical drugs with systemic action used in the past 4 weeks, prior to the planned first drug administration ,or 6 times the half-life of the respective drug, whatever is longer (excluding single use of paracetamol or ibuprofen up to 24 hours prior to the planned first drug administration). * Suspected inability, e.g. language problems, or known or suspected non-compliance, e.g. non-willingness to fulfil the dietary restrictions * Difficulty to swallow study medication * Enrolment of the investigator, his/her family members, employees and other dependent persons * Any reason which, in the opinion of the Investigator, would prevent the subject from participating the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Half Value Duration (HVD) of surrogate markers of the total extract Ze 117 | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Peak-trough fluctuation (PTF) of surrogate markers of the total extract Ze 117 | 3 days |
| Tmax of surrogate markers of the total extract Ze 117 | 3 days |
| AUCss of surrogate markers of the total extract Ze 117 | 3 days |
| Cmax of surrogate markers of the total extract Ze 117 | 3 days |
| lag time of surrogate markers of the total extract Ze 117 | 3 days |
| Mean Residence Time (MRT) of surrogate markers of the total extract Ze 117 | 3 days |
| T1/2 of surrogate markers of the total extract Ze 117 | 3 days |
| Half value Duration (HVD) of hyperforin | 3 days |
| Cmin of surrogate markers of the total extract Ze 117 | 3 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events as a Measure of Safety and Tolerability | 7 days | Physical examinations, Vital signs, 12 lead ECG, Clinical chemistry Parameters, Adverse Events records |
Countries
Germany
Outcome results
None listed