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

August 29, 2018 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Red Vine Leaf Extract
Drug: Red Vine Leaf Extract

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
maximum concentration of the analyte (Cmax)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
area under the curve (AUC) extrapolated to infinity (AUC0-inf)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean residence time (MRT)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
time to Cmax (Tmax)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
AUC under the time course of the quantifiable concentrations (AUC0-tz)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
apparent terminal disposition rate constant (λz)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
apparent terminal half-life (t1/2)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1138.9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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