Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)

An Open, Uncontrolled Trial in Healthy Volunteers to Explore the Plasma and Urinary Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)

To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this dose in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Red Vine Leaf Extract

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female (if female: either of non-childbearing potential or taking adequate contraceptive measures)
• caucasian
• age: 18 to 40 years old
• body mass index (BMI): 18-28 kg x m-2
• subjects who - on the basis of extensive pre-trial investigation - could be considered to be healthy
• subjects who were willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion Criteria:

• if female: positive pregnancy test upon recruitment
• subjects with any relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)
• subjects with chronic or relevant acute infections
• subjects with therapy-requiring allergies (including drug allergies)
• subjects with suspicion of hypersensitivity to the investigational medication
• subjects with any clinically relevant laboratory abnormality (including positive results for hepatitis and HIV serology)
• subjects who had received any medication within 1 week prior to trial start or during the trial, except for hormonal contraceptives (females) or thyroid hormone replacement after thyroidectomy
• subjects who had taken a drug with a long half-life (≥ 24 hours) within one month before enrolment in the trial
• subjects who participated in a trial with a novel investigational medication within the last 8 weeks before the start of the present trial
• subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the present trial
• subjects who donated blood or plasma within the last 4 weeks before the start of the present trial
• subjects who smoked more than 15 cigarettes per day and subjects who were not willing or able to abstain from smoking from 12:00 hours before and during the profiling days
• subjects known or suspected to be (social) drug dependent, incl. those drinking more than 60 g alcohol per day and who were not willing to abstain from alcohol during the active trial phase
• subjects adhering to a diet (i.e. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
• subjects known or suspected not to comply with the trial directives and/or known or suspected not to be reliable or trustworthy
• subjects known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red Vine Leaf Extract	Drug: Red Vine Leaf Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
maximum concentration of the analyte (Cmax)	up to 24 hours after drug administration
area under the curve (AUC) extrapolated to infinity (AUC0-inf)	up to 24 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean residence time (MRT)	up to 24 hours after drug administration
time to Cmax (Tmax)	up to 24 hours after drug administration
AUC under the time course of the quantifiable concentrations (AUC0-tz)	up to 24 hours after drug administration
apparent terminal disposition rate constant (λz)	up to 24 hours after drug administration
apparent terminal half-life (t1/2)	up to 24 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1138.9