دورية أكاديمية
Pharmacokinetics of Staccato ® alprazolam in healthy adult participants in two phase 1 studies: An open-label smoker study and a randomized, placebo-controlled ethnobridging study.
| العنوان: | Pharmacokinetics of Staccato ® alprazolam in healthy adult participants in two phase 1 studies: An open-label smoker study and a randomized, placebo-controlled ethnobridging study. |
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| المؤلفون: | Hayakawa Y; UCB Pharma, Tokyo, Japan., Rospo C; UCB Pharma, Braine-l'Alleud, Belgium., Bartmann AP; UCB Pharma, Braine-l'Alleud, Belgium., King A; UCB Pharma, Smyrna, Georgia, USA., Roebling R; UCB Pharma, Monheim am Rhein, Germany., Chanteux H; UCB Pharma, Braine-l'Alleud, Belgium. |
| المصدر: | Epilepsia [Epilepsia] 2024 Apr; Vol. 65 (4), pp. 887-899. Date of Electronic Publication: 2024 Feb 24. |
| نوع المنشور: | Randomized Controlled Trial; Clinical Trial, Phase I; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Blackwell Science Country of Publication: United States NLM ID: 2983306R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1528-1167 (Electronic) Linking ISSN: 00139580 NLM ISO Abbreviation: Epilepsia Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Malden, MA : Blackwell Science Original Publication: Copenhagen : Munskgaard |
| مواضيع طبية MeSH: | Alprazolam* , Smokers*, Adult ; Humans ; Sleepiness ; Seizures/drug therapy ; Double-Blind Method |
| مستخلص: | Objective: Staccato ® alprazolam is a single-use, drug-device combination delivering alprazolam to the deep lung that is being evaluated as treatment for rapid and early seizure termination. This article reports pharmacokinetic (PK) data from two phase 1 studies of Staccato alprazolam in healthy adult participants. Methods: The smoker study (EPK-002/NCT03516305) was an open-label, nonrandomized, single-dose, PK study in smokers and nonsmokers aged 21-50 years, administered a single inhaled dose of 1 mg Staccato alprazolam. The ethnobridging study (UP0101/NCT04782388) was a double-blind, placebo-controlled study in Japanese, Chinese, and Caucasian participants aged 18-55 years randomized 4:1 to a single inhaled dose of Staccato alprazolam 2 mg or Staccato placebo. Results: In the smoker study, 36 participants (18 smokers, 18 nonsmokers) were enrolled and received Staccato alprazolam. Following Staccato administration, alprazolam was rapidly absorbed, with a median time to peak drug plasma concentration (T Significance: Alprazolam was rapidly absorbed, and therapeutic drug levels were achieved within 2 min postdose when administered to the lung with the Staccato device. Staccato alprazolam was generally well tolerated and displayed a safety profile consistent with that known from other alprazolam applications. No new safety signals were identified. (© 2024 UCB Biopharma SRL. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.) |
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| معلومات مُعتمدة: | UCB Pharma |
| فهرسة مساهمة: | Keywords: fast onset of action; inhaled alprazolam; non‐IV formulation; prolonged seizures; rapid and early seizure termination |
| المشرفين على المادة: | YU55MQ3IZY (Alprazolam) |
| تواريخ الأحداث: | Date Created: 20240224 Date Completed: 20240416 Latest Revision: 20240419 |
| رمز التحديث: | 20240419 |
| DOI: | 10.1111/epi.17901 |
| PMID: | 38400813 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1528-1167 |
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| DOI: | 10.1111/epi.17901 |