Trial Outcomes & Findings for Amoxicillin Bioequivalence Study Brazil

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])

Results posted on

2018-06-20

Participant Flow

This is a prospective, open-label, randomized, crossover, single-dose study in which two different treatments (Test Product versus Reference Product) were administered in two sequences in two study periods. The objective was to confirm if two formulations of Amoxicillin trihydrate, in the form of powder for oral suspension, are bioequivalent.

Participant milestones

Participant milestones
Measure	Test Product in Period 1: Reference Product in Period 2 Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2	Reference Product in Period 1: Test Product in Period 2 Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
Period 1 STARTED	14	14
Period 1 COMPLETED	14	14
Period 1 NOT COMPLETED	0	0
14-Day Washout Period STARTED	14	14
14-Day Washout Period COMPLETED	14	14
14-Day Washout Period NOT COMPLETED	0	0
Period 2 STARTED	14	14
Period 2 COMPLETED	14	14
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amoxicillin Bioequivalence Study Brazil - Fast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving Both Test and Reference Products n=28 Participants Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
Age, Continuous	34.54 Years STANDARD_DEVIATION 7.38 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized White	10 participants n=5 Participants
Race/Ethnicity, Customized Black	4 participants n=5 Participants
Race/Ethnicity, Customized Mulatto	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])