Trial Outcomes & Findings for Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults (NCT NCT05205486)
NCT ID: NCT05205486
Last Updated: 2025-02-28
Results Overview
Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
8 hours
Results posted on
2025-02-28
Participant Flow
There were no pre-assignment activities for this study.
Participant milestones
| Measure |
Cefazolin 3gm Injection
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
Baseline characteristics by cohort
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Age, Continuous
|
48.1 years
STANDARD_DEVIATION 16.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Baseline Weight
|
134.82 kg
STANDARD_DEVIATION 8.133 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Only one (1) subject agreed to the 8-hour PK blood sample.
Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion.
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Cefazolin Plasma Concentration Following Infusion
8 hours post infusion
|
18.4 ug/mL
Standard Deviation NA
Cannot perform STD on a single data point
|
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Cefazolin Plasma Concentration Following Infusion
0.5 hours post infusion
|
491 ug/mL
Standard Deviation 702
|
|
Cefazolin Plasma Concentration Following Infusion
1 hour post infusion
|
117 ug/mL
Standard Deviation 25.8
|
|
Cefazolin Plasma Concentration Following Infusion
2 hours post infusion
|
99.7 ug/mL
Standard Deviation 21.6
|
|
Cefazolin Plasma Concentration Following Infusion
4 hours post infusion
|
57.9 ug/mL
Standard Deviation 34.4
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests.
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
gm/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: Hemoglobin (Hb)
Baseline
|
138.5 gm/L
Standard Deviation 18.88
|
|
Hematology: Hemoglobin (Hb)
Day 2 Discharge
|
129.8 gm/L
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: Hematocrit (Hct)
Baseline
|
0.4733 ratio
Standard Deviation 0.08105
|
|
Hematology: Hematocrit (Hct)
Day 2 Discharge
|
0.4066 ratio
Standard Deviation 0.06986
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
fL
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
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|---|---|
|
Hematology: Mean Corpuscular Volume (MCV)
Baseline
|
98.33 fL
Standard Error 10.655
|
|
Hematology: Mean Corpuscular Volume (MCV)
Day 2 Discharge
|
94.98 fL
Standard Error 9.976
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
pg
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: Mean Corpuscular Hemoglobin (MCH)
Baseline
|
28.93 pg
Standard Deviation 3.085
|
|
Hematology: Mean Corpuscular Hemoglobin (MCH)
Day 2 Discharge
|
30.20 pg
Standard Deviation 0.574
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: Mean Corpuscular Hemoglobin Concentration
Baseline
|
295.1 mmol/L
Standard Deviation 26.28
|
|
Hematology: Mean Corpuscular Hemoglobin Concentration
Day 2 Discharge
|
323.2 mmol/L
Standard Deviation 29.99
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
platelets / L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: Platelet Count
Baseline
|
315.8 10^9 platelets/L
Standard Deviation 80.08
|
|
Hematology: Platelet Count
Day 2 Discharge
|
236.0 10^9 platelets/L
Standard Deviation 48.66
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
cells/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: RBC
Baseline
|
4.811 10^12 cells / L
Standard Deviation 0.6083
|
|
Hematology: RBC
Day 2 Discharge
|
4.294 10^12 cells / L
Standard Deviation 0.2875
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
cells/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
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Hematology: WBC
Baseline
|
7.778 10^9 cells / L
Standard Deviation 1.6936
|
|
Hematology: WBC
Day 2 Discharge
|
11.170 10^9 cells / L
Standard Deviation 6.4876
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Sodium
Baseline
|
140.6 mmol / L
Standard Deviation 2.27
|
|
Clinical Chemistry: Sodium
Day 2 Discharge
|
138.8 mmol / L
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 7 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Potassium
Baseline
|
4.32 mmol / L
Standard Deviation 0.463
|
|
Clinical Chemistry: Potassium
Day 2 Discharge
|
3.99 mmol / L
Standard Deviation 0.776
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Chloride
Baseline
|
103.3 mmol / L
Standard Deviation 3.89
|
|
Clinical Chemistry: Chloride
Day 2 Discharge
|
105.5 mmol / L
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: CO2 (Bicarbonate)
Baseline
|
22.7 mmol / L
Standard Deviation 4.10
|
|
Clinical Chemistry: CO2 (Bicarbonate)
Day 2 Discharge
|
22.5 mmol / L
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Glucose
Day 2 Discharge
|
7.71 mmol / L
Standard Deviation 2.24
|
|
Clinical Chemistry: Glucose
Baseline
|
6.36 mmol / L
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
IU/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: ALT
Baseline
|
21.1 IU / L
Standard Deviation 8.35
|
|
Clinical Chemistry: ALT
Day 2 Discharge
|
28.2 IU / L
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
IU/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: AST
Baseline
|
19.6 IU / L
Standard Deviation 5.81
|
|
Clinical Chemistry: AST
Day 2 Discharge
|
39.0 IU / L
Standard Deviation 30.25
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
ukat / L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Creatine Phosphokinase (CPK)
Baseline
|
2.73 ukat / L
Standard Deviation 4.68
|
|
Clinical Chemistry: Creatine Phosphokinase (CPK)
Day 2 Discharge
|
3.76 ukat / L
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 5 subjects
IU/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Lactic Acid Dehydrogenase (LDH)
Baseline
|
238.5 IU/L
Standard Deviation 68.99
|
|
Clinical Chemistry: Lactic Acid Dehydrogenase (LDH)
Day 2 Discharge
|
216.8 IU/L
Standard Deviation 59.49
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
g/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Albumin
Baseline
|
39.8 g/L
Standard Deviation 3.71
|
|
Clinical Chemistry: Albumin
Day 2 Discharge
|
38.0 g/L
Standard Deviation 4.69
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
IU/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Alkaline Phosphatase
Baseline
|
83.08 IU/L
Standard Deviation 19.91
|
|
Clinical Chemistry: Alkaline Phosphatase
Day 2 Discharge
|
78.58 IU/L
Standard Deviation 37.15
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
umol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Uric Acid
Baseline
|
334.7 umol/L
Standard Deviation 110.5
|
|
Clinical Chemistry: Uric Acid
Day 2 Discharge
|
316.4 umol/L
Standard Deviation 128.8
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 7 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Calcium
Baseline
|
2.24 mmol/L
Standard Deviation 0.106
|
|
Clinical Chemistry: Calcium
Day 2 Discharge
|
2.11 mmol/L
Standard Deviation 0.075
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Phosphate
Day 2 Discharge
|
1.10 mmol/L
Standard Deviation 0.28
|
|
Clinical Chemistry: Phosphate
Baseline
|
1.11 mmol/L
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
g/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Total Protein
Baseline
|
66.1 g/L
Standard Deviation 3.58
|
|
Clinical Chemistry: Total Protein
Day 2 Discharge
|
67.2 g/L
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
micro-mol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=9 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Total Bilirubin
Baseline
|
7.65 micro-mol/L
Standard Deviation 4.17
|
|
Clinical Chemistry: Total Bilirubin
Day 2 Discharge
|
7.30 micro-mol/L
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
mmol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Blood Urea Nitrogen
Baseline
|
6.64 mmol/L
Standard Deviation 2.40
|
|
Clinical Chemistry: Blood Urea Nitrogen
Day 2 Discharge
|
5.63 mmol/L
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: 2 days with optional visit on Day 8Population: Medical staff only obtained clinical labs from 6 subjects
micro-mol/L
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Clinical Chemistry: Creatinine
Baseline
|
79.4 Umol/L
Standard Deviation 27.5
|
|
Clinical Chemistry: Creatinine
Day 2 Discharge
|
68.46 Umol/L
Standard Deviation 17.56
|
SECONDARY outcome
Timeframe: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgeryPopulation: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
Degree centigrade
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Temperature
End of Surgery
|
36.4 degrees centrigrade
Standard Deviation 0.28
|
|
Vital Signs: Temperature
Baseline
|
36.5 degrees centrigrade
Standard Deviation 0.41
|
|
Vital Signs: Temperature
Post-Infusion, 30-min
|
36.6 degrees centrigrade
Standard Deviation 0.32
|
|
Vital Signs: Temperature
Post-Infusion, 2-hr
|
36.6 degrees centrigrade
Standard Deviation 0.31
|
|
Vital Signs: Temperature
Post-Infusion, 4-hr
|
36.5 degrees centrigrade
Standard Deviation 0.20
|
|
Vital Signs: Temperature
Post-Infusion, 8-hr
|
36.8 degrees centrigrade
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgeryPopulation: Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint
mm Hg
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Blood Pressure (Systolic)
Baseline
|
139.8 mm Hg
Standard Deviation 17.8
|
|
Vital Signs: Blood Pressure (Systolic)
Post-Infusion, 30-min
|
127.9 mm Hg
Standard Deviation 17.3
|
|
Vital Signs: Blood Pressure (Systolic)
Post-Infusion, 2-hr
|
128.4 mm Hg
Standard Deviation 28.2
|
|
Vital Signs: Blood Pressure (Systolic)
Post-Infusion, 4-hr
|
133.9 mm Hg
Standard Deviation 16.1
|
|
Vital Signs: Blood Pressure (Systolic)
Post-Infusion, 8-hr
|
137.5 mm Hg
Standard Deviation 24.8
|
|
Vital Signs: Blood Pressure (Systolic)
End of Surgery
|
139.3 mm Hg
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgeryPopulation: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
Beats per minute
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Heart Rate
Baseline
|
79.8 beats per minute
Standard Deviation 17.1
|
|
Vital Signs: Heart Rate
Post-Infusion, 2-hr
|
79.8 beats per minute
Standard Deviation 15.3
|
|
Vital Signs: Heart Rate
Post-Infusion, 4-hr
|
77.9 beats per minute
Standard Deviation 11.6
|
|
Vital Signs: Heart Rate
Post-Infusion, 30-min
|
76.2 beats per minute
Standard Deviation 14.2
|
|
Vital Signs: Heart Rate
Post-Infusion, 8-hr
|
80.5 beats per minute
Standard Deviation 24.8
|
|
Vital Signs: Heart Rate
End of Surgery
|
78.8 beats per minute
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgeryPopulation: Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint
Breaths per minute
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Respiratory Rate
Baseline
|
17.2 Breaths per minute
Standard Deviation 2.12
|
|
Vital Signs: Respiratory Rate
Post-Infusion, 30-min
|
16.2 Breaths per minute
Standard Deviation 2.69
|
|
Vital Signs: Respiratory Rate
Post-Infusion, 2-hr
|
16.8 Breaths per minute
Standard Deviation 4.20
|
|
Vital Signs: Respiratory Rate
Post-Infusion, 4-hr
|
16.2 Breaths per minute
Standard Deviation 1.47
|
|
Vital Signs: Respiratory Rate
Post-Infusion, 8-hr
|
17.0 Breaths per minute
Standard Deviation 1.41
|
|
Vital Signs: Respiratory Rate
End of Surgery
|
16.5 Breaths per minute
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: Baselinekg
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Weight
|
134.8 kg
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Baselinecm
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Height
|
173.4 cm
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: Baselinekg/cm\^2
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: BMI
|
45.13 kg/cm^2
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: 2 daysmsec
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
ECG: PR Interval
Baseline
|
163.8 msec
Standard Deviation 44.08
|
|
ECG: PR Interval
Day 2 Discharge
|
154.2 msec
Standard Deviation 14.41
|
SECONDARY outcome
Timeframe: 2 daysmsec
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
ECG: QRS Duration
Baseline
|
84.0 msec
Standard Deviation 10.12
|
|
ECG: QRS Duration
Day 2 Discharge
|
90.2 msec
Standard Deviation 9.44
|
SECONDARY outcome
Timeframe: 2 daysmsec
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
ECG: QT Interval
Baseline
|
377.1 msec
Standard Deviation 41.19
|
|
ECG: QT Interval
Day 2 Discharge
|
398.3 msec
Standard Deviation 35.52
|
SECONDARY outcome
Timeframe: BaselinePopulation: Pregnancy was an exclusionary criteria. All women enrolled where either post-menopausal or had a negative pregnancy test.
(If appropriate) If positive, a confirmatory serum test will be performed.
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=7 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Urine Pregnancy Test
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgeryPopulation: Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint
mm Hg
Outcome measures
| Measure |
Cefazolin 3gm Injection
n=12 Participants
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).
Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing \>/= 120 kg
|
|---|---|
|
Vital Signs: Blood Pressure (Diastolic)
End of Surgery
|
81.2 mm Hg
Standard Deviation 12.6
|
|
Vital Signs: Blood Pressure (Diastolic)
Baseline
|
80.0 mm Hg
Standard Deviation 11.2
|
|
Vital Signs: Blood Pressure (Diastolic)
Post-Infusion, 30-min
|
77.7 mm Hg
Standard Deviation 8.49
|
|
Vital Signs: Blood Pressure (Diastolic)
Post-Infusion, 2-hr
|
76.8 mm Hg
Standard Deviation 17.6
|
|
Vital Signs: Blood Pressure (Diastolic)
Post-Infusion, 4-hr
|
76.8 mm Hg
Standard Deviation 11.5
|
|
Vital Signs: Blood Pressure (Diastolic)
Post-Infusion, 8-hr
|
77.0 mm Hg
Standard Deviation 14.1
|
Adverse Events
Cefazolin 3gm Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Scientific Affairs Operations
B. Braun Medical Inc.
Phone: 610-596-2512
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study data may be considered for reporting or publication. Sponsor will be responsible for these activities and may work with the investigators to determine how the manuscript is written, the number and order of authors, the journal, and other related issues. The sponsor has final approval authority over all such issues. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, which shall be in the sponsor's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER