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

NCT ID: NCT05992428

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-22
• Study Completion Date: 2023-12-05

Brief 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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 or 2

\[Part 1\] DA-8010 5mg + Paroxetine 20mg \[Part 2\] DA-8010 5mg + Mirabegron 50mg

Group Type: EXPERIMENTAL

DA-8010 5mg

Intervention Type: DRUG

\[Part 1\] DA-8010 5mg + Paroxetine 20mg \[Part 2\] DA-8010 5mg + Mirabegron 50mg

Paroxetine 20mg

Intervention Type: DRUG

\[Part 1\] DA-8010 5mg + Paroxetine 20mg

Mirabegron 50mg

Intervention Type: DRUG

\[Part 2\] DA-8010 5mg + Mirabegron 50mg

Interventions

DA-8010 5mg

\[Part 1\] DA-8010 5mg + Paroxetine 20mg \[Part 2\] DA-8010 5mg + Mirabegron 50mg

Intervention Type: DRUG

Paroxetine 20mg

\[Part 1\] DA-8010 5mg + Paroxetine 20mg

Intervention Type: DRUG

Mirabegron 50mg

\[Part 2\] DA-8010 5mg + Mirabegron 50mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Soeul, , South Korea

Countries

South Korea

Other Identifiers

DA8010_DIPM_I

Identifier Type: -

Identifier Source: org_study_id