Metformin Clinical Trial
Official title:
Inter- and Intra-individual Variations in Metformin Pharmacokinetics - The Importance of Genes and Drug Interactions
The investigators aim to investigate the interindividual variation in metformin AUC in a
large cohort of healthy volunteers after a single dose of metformin. Part 1 is driven by the
hypothesis that metformin AUC and renal clearance exhibit significant interindividual
variation. However this has never been documented in a large cohort of healthy volunteers.
The investigators aim to investigate the potential interaction between codeine and metformin
in the intestine. The hypothesis underlying part 3 is that the increased risk of early
discontinuation of metformin during co-administration with codeine is primarily due to local
inhibition of OCT1 via codeine at the intestinal level.
Part 1: The investigators intend to investigate the inter-individual variation in metformin
Area Under Plasma Concentration Curve (AUC) following a single dose of oral metformin based
on the plasma concentration of metformin after 3 and 10 hours and urine collection for 24
hours . Part 2: The investigators intend to contribute with DNA and metformin AUC
determinations from subjects from part 1 to a major international study that aime to
highlight the Genome Wide Association (GWA) between the entire genome and variations in
metformin pharmacokinetics (AUC) in a large group of healthy subjects and patients. Part 3:
The investigators aim to investigate the potential interaction between codeine and metformin
in the intestine.
The investigators secondary objective in part 3 is to investigate if the plasma concentration
of morphine increases when codeine and metformin are given together due to competitive
inhibition of the Organic cation transporter 1 (OCT1) transport protein (in the liver).
Furthermore, the investigators will measure lactate after metformin ingestion as a proxy for
metformin's effect on the intestinal mucosa, both after oral and intravenous metformin
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