NCT02505191

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Max Zeller Soehne AG · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	St. John's wort prolonged-release tablet 500 mg
DRUG	St. John's wort film coated tablets 250 mg

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-07-22
• Last updated: 2017-01-31

Locations

1 site across 1 country: Germany