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

NCT05991401 — Phase 1, Completed, 18 participants, Dong-A ST Co., Ltd.

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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

RegistryNCT05991401
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, treatment
Enrollment18 (Actual)
SponsorDong-A ST Co., Ltd. (Industry)
ConditionsHealthy
InterventionsDA-8010 5mg, Clarithromycin 500mg, Rifampicin 600mg (Drug)
Datesstart 2023-08-18, primary completion 2023-11-06, completion 2023-11-17, first posted 2023-08-14, last updated 2024-01-25
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of DA-8010 5mg All trials of Clarithromycin 500mg

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Period 1 or 2 or 3ExperimentalDrug: DA-8010 5mg; Drug: Clarithromycin 500mg; Drug: Rifampicin 600mg\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg
  • DA-8010 5mg (Drug): \[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg
  • Clarithromycin 500mg (Drug): \[Period 2\] DA-8010 5mg, Clarithromycin 500mg
  • Rifampicin 600mg (Drug): \[Period 3\] DA-8010 5mg, Rifampicin 600mg

+Outcome measures

Primary outcomes

  • Peak Plasma Concentration of DA-8010 (Cmax) [0~48hours]
  • Area under the plasma concentration versus time curve of DA-8010 (AUClast) [0~48hours]

+Eligibility

Sex: All, ages: 19 Years to 50 Years, 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

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoulSouth Korea