The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
1 x 600 mg/42.9 mg/5 mL, single-dose fed
1 x 600 mg/42.9 mg/5 mL, single-dose fed
Pharma Medica Research Inc.
Toronto, Ontario, Canada
Bioequivalence Based on Cmax for Amoxicillin
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Amoxicillin
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Time frame: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Amoxicillin
AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration
Time frame: Blood samples collected over 14 hour period
Bioequivalence Based on Cmax for Clavulanic Acid
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Clavulanic Acid
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Time frame: Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Clavulanic Acid
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Time frame: Blood samples collected over 14 hour period
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