Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

NCT05992428 — Phase 1, Completed, 37 participants, Dong-A ST Co., Ltd.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

RegistryNCT05992428
StatusCompleted
PhasePhase 1
Study typeInterventional; na, single group, masking: none, treatment
Enrollment37 (Actual)
SponsorDong-A ST Co., Ltd. (Industry)
ConditionsHealthy
InterventionsDA-8010 5mg, Paroxetine 20mg, Mirabegron 50mg (Drug)
Datesstart 2023-08-22, primary completion 2023-11-07, completion 2023-12-05, first posted 2023-08-15, 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 Paroxetine 20mg

-Summary

This is an open-label, 2-Part, phase 1 study to evaluate drug interactions when DA-8010 is co-administered with Paroxetine or Mirabegron in healthy adult subjects

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Part 1 or 2ExperimentalDrug: DA-8010 5mg; Drug: Paroxetine 20mg; Drug: Mirabegron 50mg\[Part 1\] DA-8010 5mg + Paroxetine 20mg \[Part 2\] DA-8010 5mg + Mirabegron 50mg
  • DA-8010 5mg (Drug): \[Part 1\] DA-8010 5mg + Paroxetine 20mg \[Part 2\] DA-8010 5mg + Mirabegron 50mg
  • Paroxetine 20mg (Drug): \[Part 1\] DA-8010 5mg + Paroxetine 20mg
  • Mirabegron 50mg (Drug): \[Part 2\] DA-8010 5mg + Mirabegron 50mg

+Outcome measures

Primary outcomes

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

+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
* 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
* 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 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 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 appendic 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 HospitalSoeulSouth Korea