Drug-Drug Interaction Study of Voriconazole With Clarithromycin.
Status:
Completed
Trial end date:
2018-11-30
Target enrollment:
Participant gender:
Summary
The current study evaluated the Pharmacokinetic (PK) drug-drug interaction (PK-DDI) of
voriconazole with clarithromycin in healthy male volunteers. The drug interaction study was
designed as a single oral dose, open-label, crossover, and randomized trial. In the first
phase of the study, the principal investigator developed a high-performance-liquid
chromatography (HPLC) method and validation according to standard ICH guidelines for the
quantification of voriconazole in the biological matrix. During the second step, Enrolled
volunteers were divided randomly into group A and group B by the "permuted block
randomization" technique. Then, voriconazole either alone (2 x 200mg, tab, P/O) or in
combination with clarithromycin (Voriconazole 2 x 200mg, tab + clarithromycin 500mg, tab,
P/O) was administered to enrolled volunteers in two sequences. Finally, sample collection was
carried out and blood samples were collected at specified time periods (i.e., 0.0 (pre-dose),
0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, and 24 hours) in EDTA or heparinized tubes
from the enrolled human volunteers. Further processing of the sample was done for extractions
and subsequent analysis with the developed analytical method.