Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02515526
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2015-08-01
Brief Title:
Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes NAT2 and P-glycoprotein
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes NAT2 and P-glycoprotein
Status:
COMPLETED
Status Verified Date:
2019-09
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:
Protocol title Effect of acute alcohol consumption on the activity of major cytochrome P450 enzymes NAT2 and P-glycoprotein
Objectives The study is mainly conducted to evaluate the effect of acute alcohol consumption on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2 CYP2C9 CYP2C19 CYP2D6 intestinal CYP3A4 hepatic CYP3A4 NAT2 and on the activity of the drug transporter p-glycoprotein intestinal and renal
The study should also provide basis for a planned clinical study on interactions caused by chronic alcohol intake
Design Single center open-label two-way cross-over study with randomly allocated sequences Test-Reference or Reference-Test
The study is not a clinical drug study according to the German Drug Act
Clinical phase Not applicable
Volunteers 16 healthy male and female subjects are planned for completion in accordance with the protocol ie with evaluableanalysable data for all periods and treatments
Clinical centre Department of Pharmacology Clinical Pharmacology Unit KPH University of Cologne Gleueler Str 24 50931Köln Germany
Objectives The study is mainly conducted to evaluate the effect of acute alcohol consumption on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2 CYP2C9 CYP2C19 CYP2D6 intestinal CYP3A4 hepatic CYP3A4 NAT2 and on the activity of the drug transporter p-glycoprotein intestinal and renal
The study should also provide basis for a planned clinical study on interactions caused by chronic alcohol intake
Design Single center open-label two-way cross-over study with randomly allocated sequences Test-Reference or Reference-Test
The study is not a clinical drug study according to the German Drug Act
Clinical phase Not applicable
Volunteers 16 healthy male and female subjects are planned for completion in accordance with the protocol ie with evaluableanalysable data for all periods and treatments
Clinical centre Department of Pharmacology Clinical Pharmacology Unit KPH University of Cologne Gleueler Str 24 50931Köln Germany
Detailed Description:
None
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