Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01431989 | Amoxicillin Bioequivalence Study Brazil - Fast | PHASE1 | COMPLETED | 28 | — | — | May 27, 2011 | Jun 11, 2011 | Jun 20, 2018 | 1 | Brazil |
The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method).
Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.
The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC\_%extrapolation = 100\*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.
T1/2\_Kel is calculated by using the formula T1/2\_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.
This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.
| Arm | Type | Description |
|---|---|---|
| Test formulation | ACTIVE_COMPARATOR | Test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 1; followed by 14-days washout period during which no medication was administered; followed by reference product: Amoxil® 500mg/5mL in Period 2. |
| Reference formulation | ACTIVE_COMPARATOR | Reference product: Amoxil® 500mg/5mL powder for oral suspension in Period 1; followed by 14-days washout period during which no medication was administered; followed by test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 2 |
| Name | Type | Description |
|---|---|---|
| Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL | DRUG | Test formulation |
| Amoxil® 500mg/5mL powder for oral suspension | DRUG | Reference formulation |
Inclusion Criteria: * Age between 18 and 50 years * Body mass index between 18,5 and 25,0, can vary up to 15% for the upper limit (18,5 and 28,75) * Good health conditions * Obtain signed informed consent Exclusion Criteria: * Results of laboratory tests outside the normal limits, unless they are...