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Active Not Recruiting
NCT05680792
Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
Conditions: Drug Interaction
Sex: All
Ages: 18 Years – 41 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 17
Sponsor: Obafemi Awolowo University
Location: Nigeria
Summary
The goal of this study is todetermine the most effective biological sampling method that best describe the pharmacokinetics nitazoxanide/tizoxanide and to;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
Eligibility Criteria
Inclusion Criteria:The study population will include both male and female healthy volunteers that are eighteen years or abovenon-smokers, non-alcoholics, had not taken any medication or coffee 2 weeks before participating, were non-pregnant and non-breastfeedingExclusion 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.
Source: ClinicalTrials.gov (NCT05680792). StuddyBuddy aggregates publicly available trial information.