Home > Result Summaries: Compounds > amoxicillin/clavulanic acid Result Summaries: amoxicillin/clavulanic acid GSKStudy ID Phase Title Summary (Download) 103997 phase 4 An open, non-comparative study to evaluate the efficacy and safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic acid) po q 12 hours in the treatment of uncomplicated skin and soft tissue infections in Pakistan (0 citation(s)) 112281 Phase 2 Special Drug Use Investigation for Clavamox pediatrics Drug Syrup (otitis media) (0 citation(s)) 112283 phase 4 Special Drug Use Investigation for CLAVAMOX® (amoxicillin/clavulanate) Pediatrics Dry Syrup (every indication excluded otitis media) (1 citation(s)) 115954 phase 1 Evaluation of pharmaceutical bioequivalence of Amoxicillin trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the form powder for oral suspension versus Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the form of powder for oral suspension in healthy volunteers and fasting, using techniques of Liquid Chromatography (0 citation(s)) 115983 Rechallenge Analysis: Detection of Potential Drug-Induced Liver Injury using Kaiser California Database (0 citation(s)) 116984 phase 1 Bioequivalence study of an Amoxicillin-Clavulanic Acid Suspension preparation. Cross-over, randomized, single dose, two treatments, two periods and two sequences trial in fasting conditions (0 citation(s)) 25000/233 Phase 3 A Comparison of the Efficacy and Safety of Augmentin 875/125 mg po q 12 hrs and Augmentin 500/125 mg po q 8 hrs in the Treatment of Pyelonephritis and Complicated Urinary Tract Infections. A Double-Blind, Multi-Center, Comparative Study. (0 citation(s)) 25000/234 Phase 3 A Comparison of the Efficacy and Safety of Augmentin 875/125 mg po q 12 hours versus Augmentin 500/125 mg po q 8 hours in the Treatment of Lower Respiratory Tract Infections. (3 citation(s)) 25000/311 Phase 3 A comparison of the efficacy, safety and tolerability of Augmentin 60/15 mg/kg/day (4:1 ratio) given po in three divided doses versus Augmentin™ 70/10 mg/kg/day (7:1 ratio) given po in two divided doses in the treatment of children with acute otitis media…. (1 citation(s)) 25000/314 Phase 3 A Comparison of the Efficacy and Safety of Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 10 days, Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 5 days, and Augmentin 40/10 mg/kg/day in Divided Doses q8h for 10 days in the Treatment of Acute Otitis Media in Children. (2 citation(s)) 25000/325 Phase 3 A comparison of the efficacy, safety and tolerability of Augmentin tid 20/5 mg/kg/day po versus Augmentin bid 25/3.6 mg/kg/day po in the treatment of acute bacterial lower respiratory tract infections in children. (2 citation(s)) 25000/330 Phase 3 A comparison of the efficacy, safety and tolerability of Augmentin 30/7.5 mg/kg/day po given in three divided doses (4:1 ratio) versus Augmentin 35/5 mg/kg/day po given in two divided doses (7:1 ratio) in the treatment of children with recurrent tonsillitis. (0 citation(s)) 25000/382 Phase 1 A parallel group study to estimate the steady state pharmacokinetics of amoxicillin and clavulanate in paediatric patients in the age range 1 month to 12 years administered Augmentin® 45/6.4 mg/kg/day (twice daily) or 40/10 mg/kg/day (three times daily) orally. (0 citation(s)) 25000/446 Phase 1 Comparison of Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of Augmentin 45/3.2 mg/kg to Pediatric Patients with Acute Otitis Media. (1 citation(s)) 25000/447 Phase 3 A Comparison of the Safety and Efficacy of q 12 hrs Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomized Double-Blind, Multicenter, Comparative Study. (3 citation(s)) 25000/536 Phase 3 An Open-Label Study to Demonstrate Bacteriological Efficacy of Augmentin ES in the Treatment of Acute Otitis Media Due to S. pneumoniae. (2 citation(s)) 25000/541 Phase 3 The Effect of Antimicrobial Therapy for Otitis Media on Nasopharyngeal Pneumococcal Carriage and Antibiotic Resistance. (2 citation(s)) 25000/542 Phase 1 Middle ear fluid penetration of augmentin paediatric formulation (100mg-12.5mg/ml) given as a 80mg-10mg/kg/day dosage regimen divided into three intakes. (1 citation(s)) 25000/546 Phase 3 A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 Days in the Treatment of Adults with Bacterial Community Acquired Pneumonia (7 citation(s)) 25000/547 Phase 3 An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125 mg Twice Daily for 7 days for the Treatment of Bacterial Community-Acquired Pneumonia in adults. (10 citation(s)) 25000/548 Phase 3 A Randomized, double-blind, double-dummy, multicenter, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 7 days versus oral clarithromycin 500mg twice daily for 7 days in the treatment of acute exacerbation of chronic bronchitis. (6 citation(s)) 25000/549 Phase 3 A Randomised, Double-blind, Double-dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily for 7 days versus Oral Levofloxacin 500mg Once a Day for 7 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis. (6 citation(s)) 25000/550 Phase 3 A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR, Two Tablets Equal to 2000/125mg, Twice Daily for 10 Days Versus Levofloxacin (Levaquin) 500mg Once Daily for 10 Days in the Treatment of Adults with Acute Bacterial ... (4 citation(s)) 25000/551 Phase 3 An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults. (10 citation(s)) 25000/552 Phase 1 A two-part crossover study to assess the pharmacokinetics of amoxicillin after administration with clavulanate of pharmacokinetically enhanced formulations of amoxicillin in healthy volunteers. (0 citation(s)) 25000/553 Phase 1 An open, randomised, balanced, three period, single dose crossover study to investigate the effect of food on the bioavailability of pharmacokinetically enhanced (PE) oral Augmentin® in healthy male and female volunteers. (0 citation(s)) 25000/555 Phase 3 Evaluating the Impact of Amoxicillin/Clavulanate Potassium Therapy on Carriage of Susceptible and Resistant Streptococcus pneumoniae. (0 citation(s)) 25000/556 Phase 3 A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral amoxicillin/clavulanate (Augmentin SR) 2000/125mg twice daily for 10 days versus oral amoxicillin/clavulanate 1000/125mg three times daily for 10 days for the treatment of bacter ... (10 citation(s)) 25000/557 Phase 3 A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Three Times Daily for 7 or 10 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults. (11 citation(s)) 25000/558 Phase 1 An open, randomised, four-part crossover study to investigate the relative bioavailability of three new pharmacokinetically enhanced (PE) formulations of Augmentin in comparison to the standard immediate release (IR) formulation of Augmentin in healthy volunteers. (0 citation(s)) 25000/559 Phase 4 Efficacy and tolerability of amoxicillin/clavulanate versus cefaclor for a period of 10 days in the treatment of recurrent acute otitis media in children. (0 citation(s)) 25000/563 Phase 4 A single-blind, randomized, multicentre, parallel group study to compare the efficacy and safety of Augmentin 500/125mg po bid versus Cefaclor 250mg po tid versus Cefuroxime 250mg po bid in the treatment of acute exacerbations of chronic bronchitis in Chinese adult patients. (0 citation(s)) 25000/574 Phase 1 A study to determine the pharmacokinetic profiles of amoxicillin and clavulanate over a 12 hour dosing interval in paediatric patients in the weight range of 5 to 40 kg receiving Augmentin at 45/3.2 mg/kg orally every 12 hours for up to 10 days. (0 citation(s)) 25000/575 Phase 1 A randomised, controlled and parallel phase I study to evaluate the selection of resistance to penicillin and erythromycin in the nasopharyngeal flora of adult healthy volunteers after a standard oral 7-day treatment of amoxicillin/clavulanic acid or clarithromycin or a 3-day treatment with azit ... (0 citation(s)) 25000/583 Phase 1 An open, randomised, three way crossover study to investigate the effect of Maalox on the bioavailability of pharmacokinetically enhanced oral Augmentin (BRL 25000) in healthy male and female volunteers. (0 citation(s)) 25000/590 Phase 4 Ways of use in ENT practice of a new Augmentin formulation 1g/125mg (1 intake = 2 tablets 500mg/62.5mg) in treatment of acute sinusitis in adults. (0 citation(s)) 25000/591 Phase 3 A double-blind, placebo-controlled, randomised, phase III clinical trial to compare the efficacy of oral Augmentin SR 2000/125 to placebo given as a single dose as prophylaxis or twice daily over 5 days as treatment to reduce the infective and inflammatory complications after undergoing maxillof ... (1 citation(s)) 25000/592 Phase 3 An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of Oral AUGMENTIN SR 2000/125mg Twice Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults. (9 citation(s)) 25000/593 Phase 1 A randomized open label, 4 period, crossover study to determine the bioequivalence of scored tablets of pharmacokinetically enhanced AUGMENTIN (administered as two tablets which have been broken in half) to unscored whole tablets of pharmacokinetically enhanced AUGMENTIN in healthy volunteers. (0 citation(s)) 25000/600 Phase 3 A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Twice Daily for 7 days in the Treatment of Adults with Bacterial Community Acquired Pneumonia. (6 citation(s)) 25000/601 Phase 1 A Study to Determine the Bioequivalence of Reformulated Augmentin Suspension (improved stability) to Standard Marketed Suspension. (0 citation(s)) 25000/610 Phase 1 A double blind study to compare the subject preference for Augmentin suspension formulations with alternative flavours in healthy paediatric subjects. (0 citation(s)) 25000/611 Phase 4 A Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and Children. (2 citation(s)) 25000/620 Phase 3 A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Three Times Daily for 7 or 10 Days in the Treatment of Adults with Community Acquired Pneumonia of Suspected P ... (2 citation(s)) 25000/627 Phase 3 A Randomized, Double-Blind, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily for 5 Days Versus Oral Augmentin SR 2000/125mg Twice Daily for 7 Days in the Treatment of Adults with Acute Exacerbations of Chronic Bronchitis (AECB). (1 citation(s)) 25000/630 Phase 3 A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis. (3 citation(s)) 25000/643 Phase 1 A Study to Determine the Bioequivalence of Reformulated AUGMENTIN ES-600 for Oral Suspension (improved flavor) to Standard Marketed Suspension. (0 citation(s)) 25000/654 Phase 3 A Phase III open-label, non-comparative study of BRL25000 ES-600 in paediatric patients with otitis media (1 citation(s)) 25000/665 Phase 1 An open-label, randomized, period balanced, replicate, four-period crossover bioequivalence study comparing AUGMENTIN ES-600 strawberry cream formulation to the marketed suspension. (0 citation(s)) 25000/668 Phase 1 An uncontrolled, phase I study to determine ex vivo the serum bactericidal activity against Streptococcus pneumoniae with decreased susceptibility to amoxicillin in the presence of factors of non-specific immunity with and without specific antibodies, the urine bactericidal activity against Escherichia coli w (0 citation(s)) AUG102821 phase 1 An open-label study to determine the pharmacokinetic profiles of amoxicillin and clavulanate in adolescent patients weighing at least 40 kg and no more than 16 years of age receiving Augmentin XR (amoxicillin 2000 mg/clavulanate 125 mg) orally twice daily for 10 days. (0 citation(s)) BRL-025000/672 Phase 1 An open-label, three period crossover, incomplete block study to determine the pharmacokinetics of five novel mixed component formulations of amoxicillin once-daily in healthy volunteers. (0 citation(s))
