AOD Effects and Consequences Clinical Trial
Official title:
Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes, NAT2 and P-glycoprotein
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, i.e. with evaluable/analysable data for all periods and treatments.
Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of
Cologne, Gleueler Str. 24, 50931Köln, Germany
n/a
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