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

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Rifampicin 600mg

Drug: Clarithromycin 500mg

Drug: DA-8010 5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05991401

DA8010_DICR_I

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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