Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

NCT05991401 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-01-25

No results posted yet for this study

Summary

This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.

Conditions

  • Healthy

Interventions

DRUG

DA-8010 5mg

\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg

DRUG

Clarithromycin 500mg

\[Period 2\] DA-8010 5mg, Clarithromycin 500mg

DRUG

Rifampicin 600mg

\[Period 3\] DA-8010 5mg, Rifampicin 600mg

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2023-11-06
Completion
2023-11-17

Countries

  • South Korea

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 NCT05991401 on ClinicalTrials.gov