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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-11-17

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

3-period

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1 or 2 or 3

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

Group Type EXPERIMENTAL

DA-8010 5mg

Intervention Type DRUG

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

Clarithromycin 500mg

Intervention Type DRUG

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

Rifampicin 600mg

Intervention Type DRUG

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

Interventions

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DA-8010 5mg

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

Intervention Type DRUG

Clarithromycin 500mg

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

Intervention Type DRUG

Rifampicin 600mg

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

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes