Status:
COMPLETED
Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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®). ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02191241
Start Date
August 1 2001
Last Update
August 31 2018
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