Bioequivalence Study of Oral Disintegrated Tablet of Brotizolam in Healthy Male Subjects.
|
Accession number;02A0525859
|
| Title;Bioequivalence Study of Oral Disintegrated Tablet of Brotizolam in Healthy Male Subjects. |
| Author;
TARUI SACHIYO
(Nippon Boehringer Ingelheim Co., Ltd., Kawanishi Pharm. Res. Inst.)
TATAMI SHINJI
(Nippon Boehringer Ingelheim Co., Ltd., Kawanishi Pharm. Res. Inst.)
IGARASHI TAKASHI
(Nippon Boehringer Ingelheim Co., Ltd., Kawanishi Pharm. Res. Inst.)
SEKINO HISAKUNI
(Sekino Rinsho Yakuri Kurinikku)
|
Journal Title;Journal of New Remedies & Clinics
|
Journal Code:G0596A
|
ISSN:0559-8672
|
|
VOL.51;NO.6;PAGE.480-488(2002)
|
| Figure&Table&Reference;FIG.3, TBL.5, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Oral disintegrated tablet containing 0.25 mg of brotizolam (Lendormin D tablet 0.25 mg) was newly developed. Bioequivalence of Lendormin tablet (reference) and Lendormin D tablet 0.25 mg (test) was evaluated in two open, randomized, 2-way crossover studies in 30 healthy male volunteers in the following conditions. 1) Lendormin tablet 0.25 mg dosing with water versus Lendormin D tablet 0.25 mg dosing without water. 2) Lendormin tablet 0.25 mg dosing with water versus Lendormin D tablet 0.25 mg dosing with water. In the first study, the 90% confidence intervals of the geometric mean ratio were within the range of 80-125%, with 83.5-98.9% for Cmax and 102.1-113.3% for AUC0-24hr. In the second study, the 90% confidence intervals of the geometric mean ratio were within the range of 80-125%, with 92.7-109.6% for Cmax and 94.6-105.8% for AUC0-24hr. It was therefore concluded that Lendormin tablet and Lendormin D tablet are bioequivalent as assessed by the primary pharmacokinetic parameters, Cmax and AUC0-24hr, in two conditions as mentioned above. It can be assumed that Lendormin D tablet dosing with or without water is therapeutically equivalent to Lendormin tablet and they are exchangeable in clinical practice. Due to the easy dosing, the improvement of the compliance in various patients is expected. No serious adverse events due to the drug were observed during the studies. (author abst.) |
|
|
|
Related Articles;
|
|
