Trial Outcomes & Findings for Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure (NCT NCT04384653)
NCT ID: NCT04384653
Last Updated: 2026-06-15
Results Overview
Relative absolute bioavailability of furosemide based on AUC last
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
0 to 24 hours
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
Furosemide (SC) First, Then Furosemide (IV)
Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 1 and IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 2
Furosemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution for subcutaneous administration (80 mg)
Furosemide Injection, USP: Furosemide Injection, USP (10 mg/mL), 80 mg by intravenous administration
Medfusion 3500 (v6) precision infusion pump: Furosemide Injection Solution for subcutaneous administration (80 mg)
|
Furosemide (IV) First, Then Furosemide (SC)
IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 1 and Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 2
Furosemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution for subcutaneous administration (80 mg)
Furosemide Injection, USP: Furosemide Injection, USP (10 mg/mL), 80 mg by intravenous administration
Medfusion 3500 (v6) precision infusion pump: Furosemide Injection Solution for subcutaneous administration (80 mg)
|
|---|---|---|
|
Treatment Period 1
STARTED
|
10
|
10
|
|
Treatment Period 1
COMPLETED
|
10
|
10
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 after washout
STARTED
|
10
|
10
|
|
Treatment Period 2 after washout
COMPLETED
|
10
|
10
|
|
Treatment Period 2 after washout
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Furosemide (SC), Then Furosemide (IV)
n=10 Participants
Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 1 and IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 2
Furosemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution for subcutaneous administration (80 mg)
Furosemide Injection, USP: Furosemide Injection, USP (10 mg/mL), 80 mg by intravenous administration
Medfusion 3500 (v6) precision infusion pump: Furosemide Injection Solution for subcutaneous administration (80 mg)
|
Furosemide (IV), Then Furosemide (SC)
n=10 Participants
IV Furosemide Injection, USP (80 mg) by IV bolus for Treatment Period 1 and Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for Treatment Period 2
Furosemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution for subcutaneous administration (80 mg)
Furosemide Injection, USP: Furosemide Injection, USP (10 mg/mL), 80 mg by intravenous administration
Medfusion 3500 (v6) precision infusion pump: Furosemide Injection Solution for subcutaneous administration (80 mg)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7.59 • n=20 Participants
|
68.9 years
STANDARD_DEVIATION 7.59 • n=20 Participants
|
68.9 years
STANDARD_DEVIATION 7.59 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump.
Relative absolute bioavailability of furosemide based on AUC last
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
AUC Last
|
11900 h*ng/mL
Standard Deviation 3380 • Interval 104.0 to 120.0
|
13000 h*ng/mL
Standard Deviation 2510 • Interval 104.0 to 120.0
|
SECONDARY outcome
Timeframe: 0 to 24 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump.
Cmax over 24 hours
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Cmax
|
13800 ng/mL
Standard Deviation 4100
|
2010 ng/mL
Standard Deviation 391
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump.
Tmax over 24 hours. Time to maximum plasma concentration was analyzed using non-parametric rank-based testing. Due to the nature of the statistical analysis, data are presented as Sum Scores rather than traditional descriptive time frames.
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Tmax
|
171 mins
0
|
495 mins
0
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump.
half-life
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
t1/2
|
3.67 h
Standard Deviation 1.25
|
3.71 h
Standard Deviation 0.682
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump. Urine PD for these subjects were also excluded as furosemide is responsible for natriuresis and diuresis.
Urine volume collected at 8 hours post dose
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Urine Volume at 8 Hours
|
2284.6 mL
Standard Deviation 804 • Interval 99.45 to 136.76
|
2664.3 mL
Standard Deviation 1000 • Interval 99.45 to 136.76
|
SECONDARY outcome
Timeframe: 8-24 hoursPopulation: The primary analysis of PK data excludes data from 2 subjects who did not receive the full intended subcutaneous dose of the study drug attributed to a priming error of the MedFusion pump. Urine PD for these subjects were also excluded as furosemide is responsible for natriuresis and diuresis.
Urine volume collected from 8 to 24 hours post dose
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Urine Volume at 24 Hours
|
3020.0 mL
Standard Deviation 920
|
3501.4 mL
Standard Deviation 1030
|
SECONDARY outcome
Timeframe: 0 to 8 hoursSodium concentration in urine collected from 0 to 8 hours post dose
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Sodium Concentration in Urine at 8 Hours
|
6.0218 g
Standard Deviation 1.83
|
7.1292 g
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: 8 to 24 hoursSodium concentration in urine collected from 8 to 24 hours post dose
Outcome measures
| Measure |
Furosemide (IV)
n=18 Participants
Participants who received IV Furosemide Injection, USP (80 mg) by IV bolus for either Treatment Period 1 or 2 during the study.
|
Furosemide (SC)
n=18 Participants
Participants who received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours for either Treatment Period 1 or 2 during the study.
|
|---|---|---|
|
Sodium Concentration in Urine at 8 to 24 Hours
|
7.1312 g
Standard Deviation 1.94
|
8.3381 g
Standard Deviation 2.39
|
Adverse Events
Furosemide (SC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Furosemide (IV)
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 |
Furosemide (SC)
n=20 participants at risk
Participants received Furosemide Injection Solution for subcutaneous administration (80 mg) over 5 hours
|
Furosemide (IV)
n=20 participants at risk
Participants received IV Furosemide Injection, USP (80 mg) by IV bolus
|
|---|---|---|
|
General disorders
Infusion site pain with subcutaneous infusion
|
5.0%
1/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
0.00%
0/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
|
Infections and infestations
Upper respiratory Tract Infection
|
0.00%
0/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
5.0%
1/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
5.0%
1/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
|
Vascular disorders
Orthostatic Hypotention
|
5.0%
1/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
0.00%
0/20 • Adverse events were collected from Period 1 Day 1 until Follow-up (14 days after Period 2 Day 2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place