Drug-Drug Interaction Clinical Trial
Official title:
Single-center, Open, Controlled Study to Investigate the Interaction of Metamizole With the Cytochrome p450 System in Healthy Subjects by Application of the Basel Cocktail
Investigators conducted a single center, two-phased, open, controlled pharmacokinetic study
to investigate the drug-drug interaction potential of metamizole. For this reason, healthy
male volunteers were screened.
Enrolled participants were phenotyped on day 1 using the Basel Cocktail (phenotyping cocktail
containing specific substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4). After,
they received metamizole treatment for 8 days (3 grams per day). On the 8th day (day 9), they
were phenotyped again with the Basel Cocktail and the respective phenotypes (d1 vs. d9) were
compared.
12 healthy male subjects meeting the inclusion and exclusion criteria were enrolled. On day
1, they ingested a capsule containing the Basel Cocktail (1A2: caffeine, 2B6: efavirenz, 2C9:
flurbiprofen, 2C19: omeprazole, 2D6: metoprolol, 3A4: midazolam) in fastened state. Blood
samples were withdrawn over 24 hours and the AUC ratios between metabolite and parent were
calculated to determine the phenotype.
Probands began metamizole treatment (3000 mg/day) at the day of the 24h measurement. After
3-4 day, probands were returning to the facility to ensure safety during the metamizole
treatment, blood cell count and metamizole metabolites were measured. After the 7 days of
treatment, probands were exposed again to the Basel Cocktail in a fastened state. Probands
were still exposed to metamizole to ensure potential inhibition. 24 hours plasma samples were
withdrawn, area under the curve (AUC) ratios were calculated and compared to the basal state.
After an end of study visit on the day of the 24h blood sample (following the second study
day), probands were discharged.
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