Pilot Pharmacokinetic Study of a Prolonged-release Formulation of St. John's Wort Extract Ze 117

NCT02505191 | Completed Phase 1

• 1 other identifier: Ze117-1-2014-01a
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  3 days

Secondary Outcomes (9)

• 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

• Cmin of surrogate markers of the total extract Ze 117

  3 days

Other Outcomes (1)

• Number of Adverse Events as a Measure of Safety and Tolerability

  7 days

Study Arms (2)

Test

EXPERIMENTAL

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

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

Reference

ACTIVE COMPARATOR

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

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

Interventions

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

Also known as: Prolonged-release formulation

Test

St. John's wort film coated tablets 250 mg DRUG

Also known as: Immediate-release formulation

Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Zeller Soehne AG: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

MeSH Terms

Interventions

Delayed-Action Preparations; Hypericum extract LI 160

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Drug Delivery Systems; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 22, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2016-01

Locations

DE (1)