Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
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ClinicalTrials.gov Identifier: NCT02824380 |
Recruitment Status :
Completed
First Posted : July 6, 2016
Last Update Posted : March 30, 2018
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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 | June 29, 2016 | ||
First Posted Date ICMJE | July 6, 2016 | ||
Last Update Posted Date | March 30, 2018 | ||
Actual Study Start Date ICMJE | July 2016 | ||
Actual Primary Completion Date | October 2016 (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 |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Androgenic Alopecia | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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 |
14 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | October 2016 | ||
Actual Primary Completion Date | October 2016 (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 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
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 | NCT02824380 | ||
Other Study ID Numbers ICMJE | DA4001_AGAP_I | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
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 | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |