Abstract:
BACKGROUND AND OBJECTIVE:There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modified-release formulations of clarithromycin (i.e. the originator Klacid XL and the generic Klarithran MR) were compared in patients with acute community-acquired respiratory tract infections. METHODS:Patients presenting with tonsillopharyngitis, sinusitis or pneumonia were randomized to receive either of the test drugs provided they clinically qualified for empirical clarithromycin treatment. The study endpoints were clinical and bacteriological cure rates, tolerability and safety. The study was designed to test for non-inferiority with regard to cure rates. RESULTS:The main outcome of this study was that both agents had similar clinical (non-inferior) and bacteriological cure rates and demonstrated no difference in tolerability in patients. The study also demonstrated the clinical efficacy of clarithromycin when used as empirical treatment in patients with respiratory tract infections in community practice (i.e. 95% clinical cure rate). CONCLUSION:The clarithromycin extended-release multisource product (Klarithran MR) does not differ significantly from the originator (Klacid XL) and the clinical cure rate of the generic formulation is non-inferior to that of the originator. The two formulations are tolerated similarly.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Snyman JR,Schoeman HS,Grobusch MP,Henning M,Rabie W,Hira M,Parshotam K,Mithal Y,Singh S,Ramdas Zdoi
10.2165/00044011-200929040-00005subject
Has Abstractpub_date
2009-01-01 00:00:00pages
265-74issue
4eissn
1173-2563issn
1179-1918pii
5journal_volume
29pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After ...
journal_title:Clinical drug investigation
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