Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176085
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2005-09-12
Brief Title:
Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol THCCOOH and Its Acyl-glucuronide THCCOOH-GLu After Intravenous Administration of THCCOOH in Healthy Human Subjects
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted except of one single experiment in which lacking psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual In this study however the authors did not trace the above questions due to analytical and methodological deficits
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
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
Detailed Description:
To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH 5 mg and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive For these purposes the following criteria will be studied
THCCOOH
Primary Area under the plasma concentration time curve AUCtotal Maximal plasma concentrations Cmax Time of Cmax tmax Terminal elimination half-life t12
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 t12
Secondary Systemic and renal clearance Cls CLr Volume of distribution Vc
THCCOOH
Primary Area under the plasma concentration time curve AUCtotal Maximal plasma concentrations Cmax Time of Cmax tmax Terminal elimination half-life t12
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 t12
Secondary Systemic and renal clearance Cls CLr Volume of distribution Vc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None