At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL +1 moredrug
Likely dose
Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL and Amoxil® 500mg/5mL powder for oral suspension for Infections, Bacterial. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Bacterial
CountriesBrazil
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
Primary CompletionJun 2011
First PostedSep 2011
TodayJul 2026
First PostedSep 12, 2011
Enrollment StartMay 27, 2011
Primary CompletionJun 11, 2011
TodayJul 2, 2026
Enrollment to primary: 14 daysPosted 14.8 years ago
Interventions
Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mLdrug
Test formulation
Amoxil® 500mg/5mL powder for oral suspensiondrug
Reference formulation