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Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS.

NCT05489406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-12-06

No results posted yet for this study

Summary

This relative bioavailability (RBA) study will be conducted to investigate whether there is a potential pharmacokinetic effect when paediatric DTG and F/TAF are taken together as dispersible formulations. This study will be performed in healthy volunteers instead of HIV-infected patients.

Conditions

Interventions

DRUG

DTG DT (6 x 5 mg)

DTG 5mg dispersible tablet

DRUG

F/TAF TOS (3 x 60/7.5 mg)

60/7.5 mg TOS emtricitabine/TAF

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David Burger, Prof.dr. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2023-03-24
Completion
2023-11-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT05489406 on ClinicalTrials.gov