Dec. 24, 2020 |
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May. 28, 2022 |
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jRCT2051200104 |
A Phase 1 Study of KK6483 in Healthy Male Volunteers |
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A Phase 1 Study of KK6483 in Healthy Male Volunteers |
Yagi Michio |
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Medical Corporation Heishinkai OPHAC Hospital |
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4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka |
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+81-6-6395-9000 |
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clinical.info.jp@kyowakirin.com |
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Clinical trial information contact |
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Kyowa Kirin Co., Ltd. |
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1-9-2, Otemachi , Chiyoda-ku, Tokyo |
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+81-3-5205-7200 |
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clinical.info.jp@kyowakirin.com |
Complete |
Dec. 24, 2020 |
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Jan. 06, 2021 | ||
40 | ||
Interventional |
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non-randomized controlled trial |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) Those who have provided voluntary written consent to participate in the study |
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1) Those with present illness requiring treatment |
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20age old over | ||
45age old not | ||
Male |
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Parkinson's disease |
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A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET) |
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Plasma drug concentration |
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Kyowa Kirin Co., Ltd. |
Medical Corporation Heishinkai OPHAC Hospital IRB | |
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka | |
+81-6-6395-9000 |
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sumiko.kawamoto@heishinkai.com | |
Approval | |
Dec. 11, 2020 |
No |
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none |