Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH
NCT ID: NCT00176085
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2004-10-31
2005-03-31
Brief Summary
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Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals
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Detailed Description
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THCCOOH
* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu
* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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healthy
healthy volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Smoking (regular or irregular)
* Excessive alcohol drinking (more than approximately 30 g alcohol per day)
* Positive drug screening especially THC or known or admitted drug abuse
18 Years
50 Years
MALE
Yes
Sponsors
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Heidelberg University
OTHER
Principal Investigators
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Gerd Mikus, MD BSc
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine VI
Locations
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Clinical Research Center, Department of Internal Medicine VI
Heidelberg, , Germany
Countries
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Other Identifiers
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K107
Identifier Type: -
Identifier Source: org_study_id
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