Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
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ClinicalTrials.gov Identifier: NCT05992428 |
Recruitment Status :
Completed
First Posted : August 15, 2023
Last Update Posted : January 25, 2024
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Sponsor:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
Tracking Information | |||||
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First Submitted Date ICMJE | July 27, 2023 | ||||
First Posted Date ICMJE | August 15, 2023 | ||||
Last Update Posted Date | January 25, 2024 | ||||
Actual Study Start Date ICMJE | August 22, 2023 | ||||
Actual Primary Completion Date | November 7, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults | ||||
Official Title ICMJE | 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 | ||||
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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: 2-part Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Part 1 or 2
[Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
37 | ||||
Original Estimated Enrollment ICMJE |
36 | ||||
Actual Study Completion Date ICMJE | December 5, 2023 | ||||
Actual Primary Completion Date | November 7, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05992428 | ||||
Other Study ID Numbers ICMJE | DA8010_DIPM_I | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Dong-A ST Co., Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Dong-A ST Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Dong-A ST Co., Ltd. | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |