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This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug.
The objectives of this study are:
This is an open-label, single-center, single-dose, randomized, two-way crossover study in healthy volunteers. Each Subject will complete Screening, Baseline, Treatment, and Follow-up Phases.
After a Screening Phase, Subjects meeting entry criteria will be admitted to the clinical research unit (CRU) and undergo baseline assessments. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences (IV furosemide followed by SC or vice versa). Subjects will remain domiciled in the CRU for each treatment period which will be about 12-hours. After final assessments are performed, Subjects may be discharged from the CRU if safety parameters are acceptable to the Investigator and return to the CRU after a 3-day washout period to receive the second treatment sequence. The Follow-up Phase will occur 24-48 hours after discharge from the CRU following treatment sequence 2, completing Subjects' study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Period 1: SC Period 2: IV |
|
| Treatment Sequence 2 | Experimental | Period 1: IV Period 2: SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCP-111 | Drug | Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration. | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV: |
| AUCinf | Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity. | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| AUCext | The percentage of the AUC that is extrapolated beyond the last measurable concentration. | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Cmax | Maximum observed plasma concentration of Furosemide | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Tmax | Time of maximum observed Furosemide plasma concentration | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Injection Site Pain | Injection site pain was assessed using an 11-point scale where 0 was equivalent to no pain and 10 was equivalent to the worst possible pain. | SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elixia EPCT, LLC | Tampa | Florida | 33618 | United States |
6 participants did not meet inclusion/exclusion criteria after signing informed consent.
Per protocol, participants that did not meet inclusion/exclusion criteria after signing informed consent were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 (SC Period 1; IV Period 2) | SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
| FG001 | Treatment Sequence 2 (IV Period 1; SC Period 2) | SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
Full Analysis Population (FAS): All randomized participants, regardless of whether completed study per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 (SC Period 1; IV Period 2) | SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
| BG001 | Treatment Sequence 2 (IV Period 1; SC Period 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUClast | Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration. | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | ng*hr/mL | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV: |
|
Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment.
An SAE is any AE occurring at any dose that results in any of the following outcomes:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SC SCP-111 | Pharmacokinetic Assessments after a successful SC dosing regimen | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Therapeutic Area Head, Respiratory and Cardiorenal | MannKind Corporation | 203-796-3407 | wfares@mannkindcorp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2023 | Dec 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2024 | Feb 18, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Furosemide USP | Drug | Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
|
| λz | Apparent plasma terminal-phase elimination rate constant | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| t½ | Terminal-phase half-life | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Clearance | Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F) | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Volume of Distribution, Terminal Phase | Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F) | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
| Urine Output 0-6 Hours | Total Urine Output from 0 to 6 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
| Urine Output 0-8 Hours | Total Urine Output from 0 to 8 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
| Urine Output 0-12 Hours | Total Urine Output from 0 to 12 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
| Urinary Sodium 0-6 Hours | Urinary sodium excretion from 0 to 6 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
| Urinary Sodium 0-8 Hours | Urinary sodium excretion from 0 to 8 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
| Urinary Sodium 0-12 Hours | Urinary sodium excretion from 0 to 12 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
| Urinary Potassium 0-6 Hours | Urinary potassium excretion from 0 to 6 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
| Urinary Potassium 0-8 Hours | Urinary potassium excretion from 0 to 8 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
| Urinary Potassium 0-12 Hours | Urinary potassium excretion from 0 to 12 hours | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
| NOT COMPLETED |
|
|
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| eGFR | Mean | Standard Deviation | mL/min/1.73m2 |
|
| IV Furosemide |
Pharmacokinetic Assessments after a successful IV dosing regimen |
|
|
| Primary | AUCinf | Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity. | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | ng*hr/mL | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | AUCext | The percentage of the AUC that is extrapolated beyond the last measurable concentration. | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Percentage (%) | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | Cmax | Maximum observed plasma concentration of Furosemide | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | ng/mL | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | Tmax | Time of maximum observed Furosemide plasma concentration | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Median | Full Range | hour | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | λz | Apparent plasma terminal-phase elimination rate constant | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111 | Posted | Mean | Standard Deviation | 1/hr | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | t½ | Terminal-phase half-life | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | hour | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | Clearance | Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F) | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Liter per hour | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | Volume of Distribution, Terminal Phase | Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F) | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Liter | SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. |
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| Primary | Urine Output 0-6 Hours | Total Urine Output from 0 to 6 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Liter | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
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| Primary | Urine Output 0-8 Hours | Total Urine Output from 0 to 8 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Liter | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
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| Primary | Urine Output 0-12 Hours | Total Urine Output from 0 to 12 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | Liter | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
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| Primary | Urinary Sodium 0-6 Hours | Urinary sodium excretion from 0 to 6 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mmol | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
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| Primary | Urinary Sodium 0-8 Hours | Urinary sodium excretion from 0 to 8 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mmol | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
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| Primary | Urinary Sodium 0-12 Hours | Urinary sodium excretion from 0 to 12 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mmol | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
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| Primary | Urinary Potassium 0-6 Hours | Urinary potassium excretion from 0 to 6 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mEq | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose |
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| Primary | Urinary Potassium 0-8 Hours | Urinary potassium excretion from 0 to 8 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mEq | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose |
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| Primary | Urinary Potassium 0-12 Hours | Urinary potassium excretion from 0 to 12 hours | Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111. | Posted | Mean | Standard Deviation | mEq | 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose |
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| Secondary | Injection Site Pain | Injection site pain was assessed using an 11-point scale where 0 was equivalent to no pain and 10 was equivalent to the worst possible pain. | Safety Population: All randomized participants who received at least 1 dose of either study drug and provided at least 1 post-baseline safety assessment. | Posted | Median | Full Range | score on a scale | SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dose |
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| 21 |
| 1 |
| 21 |
| 11 |
| 21 |
| EG001 | IV Furosemide | Pharmacokinetic Assessments after a successful IV dosing regimen | 0 | 20 | 0 | 20 | 7 | 20 |
| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Injection site bruising | General disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Injection site mass | General disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (27.0) | Non-systematic Assessment |
|
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