A Phase 1, randomized, open-label, three-period crossover study to evaluate pharmacokinetics, dose proportionality, and safety after single intranasal administration of NRL-1 (diazepam, spray) in healthy Japanese subjects
日本人健康被験者を対象とするNRL-1の単回鼻腔内投与による用量比例性試験
Dose proportional study after single doses intranasal administration of NRL-1 in healthy Japanese subjects
(2)治験責任医師等に関する事項
高沢 謙二
Takazawa Kenji
/
医療法人社団信濃会 信濃坂クリニック
Medical Corporation Shinanokai Shinanozaka Clinic
107-0061
/
東京都港区北青山2-14-4 ジ アーガイル アオヤマ 6F
the ARGYLE aoyama 6F, 2-14-4 KitaAoyama, Minato-ku, Tokyo
090-3633-3970
jonuma@aculys.com
小沼 淳一
Onuma Junichi
アキュリスファーマ株式会社
Aculys Pharma, Inc.
研究開発本部 臨床開発部/ R&D, Clinical Development
107-0061
東京都港区北青山2-14-4 ジ アーガイル アオヤマ 6F
the ARGYLE aoyama 6F, 2-14-4 KitaAoyama, Minato-ku, Tokyo
- Japanese males between the ages of 18 and 45 years, inclusive.
- Subjects weigh 51 to 111 kg, inclusive, and have a body mass index (BMI) between 18 and 29 kg/m2, inclusive, at Screening.
A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non-seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Investigator or Subinvestigator, may jeopardize the safety of the subject or impact the validity of the study results including chronic rhinitis.
年齢下限 / Age Minimum
18歳 以上
18age old over
年齢上限 / Age Maximum
45歳 以下
45age old under
性別 / Gender
男性
Male
中止基準
対象疾患名 / Health Condition(s) or Problem(s) Studied
てんかん重積状態又はてんかん重積状態に移行する恐れのある発作
status epilepticus or seizures that may progress to status epilepticus
対象疾患コード / Code
対象疾患キーワード / Keyword
介入の有無
あり
介入の内容 / Intervention(s)
NRL-1(ジアゼパム スプレー式点鼻薬)の単回鼻腔内投与
Single intranasal administration of NRL-1 (diazepam, spray)