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
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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