No clinically significant safety or pharmacokinetic/pharmacodynamic interactions were observed with coadministered chloroquine and tafenoquine in healthy subjects.
Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects.
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Study Design
Healthy subjects, 18-55 years old, without documented glucose-6-phosphate dehydrogenase deficiency, received CQ alone (days 1-2, 600 mg; and day 3, 300 mg), TQ alone (days 2 and 3, 450 mg) or coadministration therapy (day 1, CQ 600 mg; day 2, CQ 600 mg TQ 450 mg; and day 3, CQ 300 mg TQ 450 mg) in a randomized, double-blind, parallel-group study. Blood samples for pharmacokinetic and pharmacodynamic analyses and safety data, including electrocardiograms, were collected for 56 days.
Study Results
The coadministration of CQ TQ had no effect on TQ AUC0-t , AUC0-&8734; , Tmax or t1/2 . The 90 confidence intervals of CQ TQ vs. TQ for AUC0-t , AUC0-&8734; and t1/2 indicated no drug interaction. On day 2 of CQ TQ coadministration, TQ Cmax and AUC0-24 increased by 38 (90 confidence interval 1.27, 1.64) and 24 (90 confidence interval 1.04, 1.46), respectively. The pharmacokinetics of CQ and its primary metabolite desethylchloroquine were not affected by TQ. Coadministration had no clinically significant effect on QT intervals and was well tolerated.
Study Conclusions
No clinically significant safety or pharmacokinetic/pharmacodynamic interactions were observed with coadministered CQ and TQ in healthy subjects.
References
Miller, AK. Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects. Br J Clin Pahrmacol. 2013; 6: 858-67.
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