Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
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
Timeline
- Start
- 2020-09-10
- Primary completion
- 2023-01-10
- Completion
- 2023-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 300 mg | Oral |
| Subject | Nitazoxanide | Other / unclassified | 1000 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
Indications
No indication recorded.