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Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers

NCT05680792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-09-13

No results posted yet for this study

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

Conditions

  • Drug Interaction

Interventions

DRUG

Nitazoxanide

1000 mg nitazoxanide tablets twice daily. The drug will be administered after meal for 5 days

DRUG

Atazanavir/ritonavir

300/100 mg atazanavir/ritonavir tablets in the evening once daily, to be administered after meal for 5 days.

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • Obafemi Awolowo University

    lead OTHER

Principal Investigators

  • Babatunde A Adeagbo, PhD · Obafemi Awolowo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2023-01-10
Completion
2023-01-31

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680792 on ClinicalTrials.gov