| 介入/Intervention |
| 群数/No. of arms |
8 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
OPF1群（OPF-105、550 mL、2時間） |
OPF1 group (OPF-105, 550 mL, 2 hours) |
| 介入2/Interventions/Control_2 |
BFI1群（BFI、500 mL、2時間） |
BFI1 group (BFI, 500 mL, 2 hours) |
| 介入3/Interventions/Control_3 |
OPF2群（OPF-105、1100 mL、4時間） |
OPF2 group (OPF-105, 1100 mL, 4 hours) |
| 介入4/Interventions/Control_4 |
BFI2群（BFI、1000 mL、4時間） |
BFI2 group (BFI, 1000 mL, 4 hours) |
| 介入5/Interventions/Control_5 |
OPF3群（OPF-105、2200 mL、8時間） |
OPF3 group (OPF-105, 2200 mL, 8 hours) |
| 介入6/Interventions/Control_6 |
BFI3群（BFI、2000 mL、8時間） |
BFI3 group (BFI, 2000 mL, 8 hours) |
| 介入7/Interventions/Control_7 |
OPF4群（OPF-105、2200 mL/日×3日間、8時間/日×3日間） |
OPF4 group (OPF-105, 2200 mL/day x 3days, 8 hours/day x 3days) |
| 介入8/Interventions/Control_8 |
BFI4群（BFI、2000 mL/日×3日間、8時間/日×3日間） |
BFI4 group (BFI, 2000 mL/day x 3days, 8 hours /day x 3days) |
| 介入9/Interventions/Control_9 |
|
|
| 介入10/Interventions/Control_10 |
|
|
| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
|
| 年齢（上限）/Age-upper limit |
|
| 性別/Gender |
男/Male |
| 選択基準/Key inclusion criteria |
(1) 同意取得時の年齢が20歳以上40歳未満の者
(2) 両腕に何ら異常を認めず、末梢静脈路確保が可能な者
(3) 肥満度：Body mass indexが18.5以上、30.0未満の者
(4) 被験者本人から文書同意取得が可能な者 |
(1) Those who aged 20 or over to under 40 at the time of obtaining consent
(2) Those who are observed no abnormalities in both arms and are able to establish peripheral venous access
(3) Those whose body mass index is 18.5 or more and less than 30.0
(4) Those who provided written informed consent |
| 除外基準/Key exclusion criteria |
(1) 消化器、肝機能、腎機能、心血管系、血液系、内分泌系、脂質代謝の異常（これらの既往歴を含む）を有し、本治験の参加に支障があると治験責任医師又は治験分担医師が判断した者
(2) 自覚症状・他覚所見、バイタルサイン又は臨床検査の観察・測定結果から、治験責任医師又は治験分担医師が本治験の被験者として不適格と判断した者
(3) 感染症検査（B型肝炎、C型肝炎、HIV、梅毒のいずれか）が陽性であった者
(4) 治験薬の配合成分に対する過敏症の既往歴がある者
(5) 同意取得日の前4週間以内 に200 mLを超える採血又は献血、あるいは、同意取得日の前12週間以内に400 mLを超える採血又は献血をした者
(6) 同意取得日の前16週間以内に他の治験又は薬物の投与を伴う臨床研究に参加した者
(7) アルコール依存、薬物依存又はこれらの既往歴がある者
(8) 被験者登録日の前2週間以内 に医薬品（一般用医薬品を含む）及び保健機能食品（治験責任医師又は治験分担医師が本治験に影響を及ぼすと判断したもの）を使用した者
(9) その他、治験責任医師又は治験分担医師が本治験の対象として不適格と判断した者 |
(1) Those who have gastrointestinal, hepatic, renal, cardiovascular, blood, endocrine, and lipid metabolism abnormalities (including a history of these) and are determined to be difficult to participate in the clinical trial by the principal investigator or sub-investigator
(2) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator based on the subjective symptoms/objective findings, vital signs, or observation/measurement results of clinical tests
(3) Those who tested positive for infectious diseases (hepatitis B, hepatitis C, HIV, or syphilis)
(4) Those who have a history of hypersensitivity to the ingredients of the test or control solutions
(5) Those who underwent blood sampling or participated in blood donation of more than 200 mL within 4 weeks before the informed consent was obtained
Those who underwent blood sampling or participated in blood donation of more than 400 mL, within 12 weeks before the day of obtaining informed consent
(6) Those who participated in a clinical trial or clinical study and received a drug within 16 weeks before the day of obtaining informed consent
(7) Those who have a history or presence of alcohol or drug abuse
(8) Those who used drugs (including over-the-counter drugs) and consumed foods with health claims (those judged by the principal investigator or sub-investigator to affect this trial) within 2 weeks before the participant registration date
(9) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator for any other reasons |
| 目標参加者数/Target sample size |
48 |
| 責任研究者/Research contact person |
| 責任研究者/Name of lead principal investigator |
|
| 名 |
Yoshiyuki |
| ミドルネーム |
|
| 姓 |
Kawauchi |
|
| 所属組織/Organization |
株式会社大塚製薬工場 |
Otsuka Pharmaceutical Factory, Inc. |
| 所属部署/Division name |
研究開発センター 開発部 |
Clinical Development Department, Research and Development Center |
| 郵便番号/Zip code |
101-0052 |
| 住所/Address |
東京都千代田区神田小川町1-1 日幸神田ビル5階 |
Nikko Kanda Bldg. 5F, 1-1 Kanda-Ogawamachi Chiyoda-ku Tokyo, Japan |
| 電話/TEL |
03-5280-2721 |
| Email/Email |
Kawauchi.Yoshiyuki@otsuka.jp |
| 試験問い合わせ窓口/Public contact |
| 試験問い合わせ窓口担当者/Name of contact person |
|
| 名 |
Satoshi |
| ミドルネーム |
|
| 姓 |
Katayose |
|
| 組織名/Organization |
株式会社大塚製薬工場 |
Otsuka Pharmaceutical Factory, Inc. |
| 部署名/Division name |
研究開発センター 開発部 |
Clinical Development Department, Research and Development Center |
| 郵便番号/Zip code |
101-0052 |
| 住所/Address |
東京都千代田区神田小川町1-1 日幸神田ビル5階 |
Nikko Kanda Bldg. 5F, 1-1 Kanda-Ogawamachi Chiyoda-ku Tokyo, Japan |
| 電話/TEL |
03-5280-2721 |
| 試験のホームページURL/Homepage URL |
|
| Email/Email |
Katayose.Satoshi@otsuka.jp |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
|
| 組み入れ参加者数/Number of participants that the trial has enrolled |
48 |
| 主な結果/Results |
|
|
| 主な結果入力日/Results date posted |
|
| 結果掲載遅延/Results Delayed |
|
| 結果遅延理由/Results Delay Reason |
論文投稿中のため |
Due to submitting the paper |
| 最初の試験結果の出版日/Date of the first journal publication of results |
|
| 参加者背景/Baseline Characteristics |
|
|
| 参加者の流れ/Participant flow |
|
|
| 有害事象/Adverse events |
|
|
| 評価項目/Outcome measures |
|
|
| 個別症例データ共有計画/Plan to share IPD |
|
|
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
|
|
UMIN-CTR 臨床試験登録情報の閲覧