Trial Outcomes & Findings for Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel (NCT NCT01591616)
NCT ID: NCT01591616
Last Updated: 2020-08-07
Results Overview
The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
5, 10, 15, 30, 60, 90, 120, and 240 minutes
Results posted on
2020-08-07
Participant Flow
Participant milestones
| Measure |
Oraqix for Tooth Extraction
lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Oraqix for Tooth Extraction
lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Baseline characteristics by cohort
| Measure |
Oraqix for Tooth Extraction
n=16 Participants
lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
|
|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5, 10, 15, 30, 60, 90, 120, and 240 minutesThe study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=11 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics
|
89.9 ng/mL
Geometric Coefficient of Variation 66
|
41.8 ng/mL
Geometric Coefficient of Variation 60.6
|
3.72 ng/mL
Geometric Coefficient of Variation 48.5
|
5.13 ng/mL
Geometric Coefficient of Variation 51.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5, 10, 15, 30, 60, 90, 120, and 240 minutesThe study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=11 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics
|
0.500 hours
Interval 0.0833 to 0.65
|
0.500 hours
Interval 0.0833 to 0.65
|
1.50 hours
Interval 0.65 to 4.0
|
1.50 hours
Interval 1.0 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: blood draws pre-dose, 2 and 4 hours postdoseThe % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose. ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals. Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose. For each subject, phone call was made at +24h as follow up pursuant to the protocol.
Outcome measures
| Measure |
Lidocaine Cmax
n=16 Participants
|
Prilocaine Cmax
n=16 Participants
|
2,6-xylidine Cmax
n=16 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety
|
1.3 Percentage MetHb
Standard Deviation 0.24
|
1.3 Percentage MetHb
Standard Deviation 0.26
|
1.2 Percentage MetHb
Standard Deviation 0.20
|
1.2 Percentage MetHb
Standard Deviation 0.20
|
1.3 Percentage MetHb
Standard Deviation 0.18
|
1.5 Percentage MetHb
Standard Deviation 0.43
|
1.5 Percentage MetHb
Standard Deviation 0.20
|
1.6 Percentage MetHb
Standard Deviation 0.19
|
1.7 Percentage MetHb
Standard Deviation 0.28
|
1.7 Percentage MetHb
Standard Deviation 0.30
|
1.5 Percentage MetHb
Standard Deviation 0.35
|
1.5 Percentage MetHb
Standard Deviation 0.40
|
1.5 Percentage MetHb
Standard Deviation 0.39
|
1.6 Percentage MetHb
Standard Deviation 0.19
|
1.5 Percentage MetHb
Standard Deviation 0.32
|
1.5 Percentage MetHb
Standard Deviation 0.29
|
1.4 Percentage MetHb
Standard Deviation 0.28
|
1.4 Percentage MetHb
Standard Deviation 0.26
|
1.3 Percentage MetHb
Standard Deviation 0.34
|
1.2 Percentage MetHb
Standard Deviation 0.47
|
1.4 Percentage MetHb
Standard Deviation 0.15
|
1.4 Percentage MetHb
Standard Deviation 0.17
|
1.5 Percentage MetHb
Standard Deviation 0.20
|
1.4 Percentage MetHb
Standard Deviation 0.18
|
1.4 Percentage MetHb
Standard Deviation 0.13
|
1.5 Percentage MetHb
Standard Deviation 0.14
|
1.4 Percentage MetHb
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Pre-dose and every 10 minute to 240 minutes post-dose.Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
Outcome measures
| Measure |
Lidocaine Cmax
n=16 Participants
|
Prilocaine Cmax
n=16 Participants
|
2,6-xylidine Cmax
n=16 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs (Pulse)
|
74 Beats per minute
Interval 58.0 to 98.0
|
72 Beats per minute
Interval 54.0 to 90.0
|
72 Beats per minute
Interval 60.0 to 95.0
|
79 Beats per minute
Interval 59.0 to 101.0
|
71 Beats per minute
Interval 58.0 to 89.0
|
72 Beats per minute
Interval 56.0 to 94.0
|
71 Beats per minute
Interval 55.0 to 86.0
|
70 Beats per minute
Interval 54.0 to 86.0
|
71 Beats per minute
Interval 55.0 to 86.0
|
74 Beats per minute
Interval 61.0 to 89.0
|
72 Beats per minute
Interval 57.0 to 86.0
|
71 Beats per minute
Interval 53.0 to 90.0
|
70 Beats per minute
Interval 54.0 to 91.0
|
72 Beats per minute
Interval 57.0 to 88.0
|
70 Beats per minute
Interval 52.0 to 86.0
|
71 Beats per minute
Interval 58.0 to 91.0
|
72 Beats per minute
Interval 53.0 to 97.0
|
72 Beats per minute
Interval 55.0 to 98.0
|
74 Beats per minute
Interval 58.0 to 93.0
|
74 Beats per minute
Interval 57.0 to 100.0
|
73 Beats per minute
Interval 53.0 to 91.0
|
72 Beats per minute
Interval 50.0 to 90.0
|
75 Beats per minute
Interval 62.0 to 90.0
|
72 Beats per minute
Interval 54.0 to 97.0
|
70 Beats per minute
Interval 53.0 to 96.0
|
72 Beats per minute
Interval 57.0 to 96.0
|
77 Beats per minute
Interval 62.0 to 101.0
|
SECONDARY outcome
Timeframe: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.Outcome measures
| Measure |
Lidocaine Cmax
n=16 Participants
|
Prilocaine Cmax
n=16 Participants
|
2,6-xylidine Cmax
n=16 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs (Systolic Pressure)
|
110 mmHg
Standard Deviation 11.5
|
104 mmHg
Standard Deviation 9.4
|
106 mmHg
Standard Deviation 9.1
|
115 mmHg
Standard Deviation 9.7
|
109 mmHg
Standard Deviation 7.9
|
108 mmHg
Standard Deviation 9.4
|
106 mmHg
Standard Deviation 9.8
|
106 mmHg
Standard Deviation 9.6
|
105 mmHg
Standard Deviation 12.1
|
106 mmHg
Standard Deviation 7.9
|
104 mmHg
Standard Deviation 11.0
|
106 mmHg
Standard Deviation 9.7
|
106 mmHg
Standard Deviation 9.9
|
106 mmHg
Standard Deviation 10.7
|
106 mmHg
Standard Deviation 11.4
|
105 mmHg
Standard Deviation 8.9
|
108 mmHg
Standard Deviation 8.0
|
107 mmHg
Standard Deviation 8.4
|
105 mmHg
Standard Deviation 10.7
|
106 mmHg
Standard Deviation 9.6
|
104 mmHg
Standard Deviation 10.2
|
103 mmHg
Standard Deviation 10.7
|
103 mmHg
Standard Deviation 10.9
|
102 mmHg
Standard Deviation 9.2
|
104 mmHg
Standard Deviation 10.8
|
102 mmHg
Standard Deviation 10.6
|
102 mmHg
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post doseOutcome measures
| Measure |
Lidocaine Cmax
n=16 Participants
|
Prilocaine Cmax
n=16 Participants
|
2,6-xylidine Cmax
n=16 Participants
|
O-toluidine Cmax
n=15 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
n=14 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
n=16 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
n=15 Participants
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs (Diastolic Pressure)
|
63 mmHg
Standard Deviation 6.8
|
60 mmHg
Standard Deviation 7.2
|
63 mmHg
Standard Deviation 7.2
|
69 mmHg
Standard Deviation 7.9
|
63 mmHg
Standard Deviation 6.2
|
64 mmHg
Standard Deviation 5.6
|
62 mmHg
Standard Deviation 8.7
|
62 mmHg
Standard Deviation 11.2
|
62 mmHg
Standard Deviation 7.7
|
62 mmHg
Standard Deviation 10.8
|
62 mmHg
Standard Deviation 9.3
|
64 mmHg
Standard Deviation 7.6
|
63 mmHg
Standard Deviation 7.6
|
63 mmHg
Standard Deviation 11.4
|
60 mmHg
Standard Deviation 7.6
|
62 mmHg
Standard Deviation 7.9
|
62 mmHg
Standard Deviation 7.2
|
63 mmHg
Standard Deviation 9.1
|
63 mmHg
Standard Deviation 6.6
|
60 mmHg
Standard Deviation 6.8
|
60 mmHg
Standard Deviation 8.8
|
61 mmHg
Standard Deviation 7.1
|
60 mmHg
Standard Deviation 7.6
|
59 mmHg
Standard Deviation 7.5
|
57 mmHg
Standard Deviation 6.9
|
57 mmHg
Standard Deviation 6.9
|
60 mmHg
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=15 Participants
|
O-toluidine Cmax
n=16 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs (Ventricular Heart Rate)
|
73 Beats per minute
Standard Deviation 9.9
|
70 Beats per minute
Standard Deviation 8.3
|
71 Beats per minute
Standard Deviation 6.5
|
74 Beats per minute
Standard Deviation 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=15 Participants
|
O-toluidine Cmax
n=16 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs (PR Interval)
|
148 milliseconds
Standard Deviation 21.1
|
147 milliseconds
Standard Deviation 23.7
|
147 milliseconds
Standard Deviation 22.4
|
139 milliseconds
Standard Deviation 18.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=15 Participants
|
O-toluidine Cmax
n=16 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs (QRS Duration)
|
77 milliseconds
Standard Deviation 5.7
|
76 milliseconds
Standard Deviation 4.5
|
75 milliseconds
Standard Deviation 7.5
|
74 milliseconds
Standard Deviation 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=15 Participants
|
O-toluidine Cmax
n=16 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs (QT Interval)
|
376 milliseconds
Standard Deviation 22.5
|
384 milliseconds
Standard Deviation 19.3
|
383 milliseconds
Standard Deviation 19.0
|
379 milliseconds
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1 hour, 2 hour, 4 hour post-dose.Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.
Outcome measures
| Measure |
Lidocaine Cmax
n=15 Participants
|
Prilocaine Cmax
n=15 Participants
|
2,6-xylidine Cmax
n=15 Participants
|
O-toluidine Cmax
n=16 Participants
|
% MetHemoglobin (MetHb) Time Point 20 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 30 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 40 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 50 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 60 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 70 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 80 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 90 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 100 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 110 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 120 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 130 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 140 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 150 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 160 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 170 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 180 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 190 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 200 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 210 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 220 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 230 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
% MetHemoglobin (MetHb) Time Point 240 Minutes
The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs (QTcB Interval)
|
412 milliseconds
Standard Deviation 19.0
|
413 milliseconds
Standard Deviation 21.9
|
415 milliseconds
Standard Deviation 18.6
|
419 milliseconds
Standard Deviation 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Adverse Events
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adverse Events
n=16 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16
|
|
Gastrointestinal disorders
Gagging
|
6.2%
1/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
|
Nervous system disorders
Tooth pain
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
6.2%
1/16
|
Additional Information
Tegwyn H. Brickhouse, DDS, PhD
Virginia Commonwealth University, School of Dentistry
Phone: (804) 827-2699
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The subject study was a post-approval requirement related to the approval of NDA 21-451 to evaluate the pharmacokinetics and safety of the Oraqix gel in pediatric patients. As the purpose of the study was solely to fulfill a post approval regulatory requirement, the information is considered proprietary to the sponsor (Dentsply International, Inc.) and disclosure by the Investigators to any third party (unless such disclosure was required by government regulations or laws) was prohibited.
- Publication restrictions are in place
Restriction type: OTHER