A Pilot Phase I, Randomised, Open Mono-center, Multiple Dose, Two Parallel Groups 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

Max Zeller Soehne AG1 site in 1 country10 target enrollmentNovember 2015

ConditionsHealthy

InterventionsSt. John's wort prolonged-release tablet 500 mg St. John's wort film coated tablets 250 mg

DrugsSt. John's wort prolonged-release tablet 500 mg St. John's wort film coated tablets 250 mg

Overview

Phase: Phase 1
Intervention: St. John's wort prolonged-release tablet 500 mg
Conditions: Healthy
Sponsor: Max Zeller Soehne AG
Enrollment: 10
Locations: 1
Primary Endpoint: Half Value Duration (HVD) of surrogate markers of the total extract Ze 117
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

November 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Max Zeller Soehne AG

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Test

St. John's wort prolonged-release tablet 500 mg

Intervention: St. John's wort prolonged-release tablet 500 mg

Reference

St. John's wort film coated tablets 250 mg (Remotiv N)

Intervention: St. John's wort film coated tablets 250 mg

Outcomes

Primary Outcomes

Half Value Duration (HVD) of surrogate markers of the total extract Ze 117

Time Frame: 3 days

Secondary Outcomes

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)
Cmin of surrogate markers of the total extract Ze 117(3 days)
lag time of surrogate markers of the total extract Ze 117(3 days)
T1/2 of surrogate markers of the total extract Ze 117(3 days)
Peak-trough fluctuation (PTF) 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)
Half value Duration (HVD) of hyperforin(3 days)