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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: DA-8010 5mg
* Drug: Clarithromycin 500mg
* Drug: Rifampicin 600mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteer 19 years to 50 years Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2 In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.) The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire Exclusion Criteria: Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease, sexual disorder, ophthalmologic or history of such disease Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery) Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.) Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test) Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 3-period
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1 or 2 or 3<br>[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg | Drug: DA-8010 5mg<br>* [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg<br>Drug: Clarithromycin 500mg<br>* [Period 2] DA-8010 5mg, Clarithromycin 500mg<br>Drug: Rifampicin 600mg<br>* [Period 3] DA-8010 5mg, Rifampicin 600mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration of DA-8010 (Cmax) |  | 0 48hours | 
| Area under the plasma concentration versus time curve of DA-8010 (AUClast) |  | 0 48hours |