Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers

• Status: Active, not recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Obafemi Awolowo University
• Collaborator: University of Liverpool
• Treatments: Atazanavir Sulfate; Nitazoxanide; Ritonavir

Criteria

Inclusion Criteria:

• The study population will include both male and female healthy volunteers that are eighteen years or above

• non-smokers, non-alcoholics, had not taken any medication or coffee 2 weeks before participating, were non-pregnant and non-breastfeeding

Exclusion Criteria:

• Pregnant women will be excluded from the study. Moreover, volunteers who have been on any other drugs in the last two weeks will also be excluded from the study.

• Exclusion criteria included any sickness or reaction to the study drugs.