Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
Status:
Active, not recruiting
Trial end date:
2023-01-31
Target enrollment:
Participant gender:
Summary
The goal of this study is to
1. determine the most effective biological sampling method that best describe the
pharmacokinetics nitazoxanide/tizoxanide and to;
2. evaluate the clinical significance of the pharmacokinetics interaction between
nitazoxanide (1000mg twice daily) and atazanavir/ritonavir (300mg/100mg).
Participants will be given 1000mg oral nitazoxanide taken twice daily for seven days. After a
washout period of three weeks, they will receive 1000mg oral nitazoxanide with
atazanavir/ritonavir (taken orally at 300/100 mg). Five millimetres of whole blood or swab or
saliva samples will be collected from them at 0.5, 1, 2, 4, 6, 8 and 12 hours after dose on
day 1, 5 and 7.
The pharmacokinetic of nitazoxanide when administered alone and alongside
atazanavir/ritonavir will be compared to see if concomitant administration of nitazoxanide
and atazanavir/ritonavir affect nitazoxanide pharmacokinetics