Trial Outcomes & Findings for Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers (NCT NCT04982874)

NCT ID: NCT04982874

Last Updated: 2023-11-02

Results Overview

The ratio between test drug and reference drug

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration
• Results posted on: 2023-11-02

Participant Flow

24 healthy volunteers were recruited from one research

Participant milestones

Measure	Test Drug First, Then Reference Drug New (test) Furosemide 40 mg tablet with 240 mL of water as a single oral dose in the first intervention period, and marketed (reference) Lasix® 40 mg tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period).	Reference Drug First, Then Test Drug Marketed (reference) Lasix® 40 mg tablet with 240 mL of water as a single oral dose in the first intervention period, and new (test) Furosemide 40 mg tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period)
1st Intervention STARTED	12	12
1st Intervention COMPLETED	12	12
1st Intervention NOT COMPLETED	0	0
Washout Periods >= One Week STARTED	12	12
Washout Periods >= One Week COMPLETED	12	12
Washout Periods >= One Week NOT COMPLETED	0	0
2nd Intervention STARTED	12	12
2nd Intervention COMPLETED	12	12
2nd Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total Number of Participants n=24 Participants All volunteers received Furosemide 40 mg tablet with 240 mL of water new and marketed)
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Sex: Female, Male Female	8 Participants n=24 Participants
Sex: Female, Male Male	16 Participants n=24 Participants

PRIMARY outcome

Timeframe: before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration

The ratio between test drug and reference drug

Outcome measures

Measure	Furosemide 40 mg Tablet n=24 Participants All volunteers received Furosemide 40 mg tablet with 240 mL of water (new and marketed drug)	Lasix® 40 mg Tablet volunteers received Lasix® 40 mg tablet with 240 mL of water (marketed drug)
Geometric Mean Ratio of Maximum Concentration	104.51 percentage Interval 90.81 to 120.29	—

PRIMARY outcome

Timeframe: before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration

The ratio between test drug and reference drug

Outcome measures

Measure	Furosemide 40 mg Tablet n=24 Participants All volunteers received Furosemide 40 mg tablet with 240 mL of water (new and marketed drug)	Lasix® 40 mg Tablet volunteers received Lasix® 40 mg tablet with 240 mL of water (marketed drug)
Geometric Mean Ratio of Area Under Curve	101.79 percentage Interval 95.08 to 108.98	—

SECONDARY outcome

Timeframe: before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration

Maximum plasma concentration

Outcome measures

Measure	Furosemide 40 mg Tablet n=24 Participants All volunteers received Furosemide 40 mg tablet with 240 mL of water (new and marketed drug)	Lasix® 40 mg Tablet n=24 Participants volunteers received Lasix® 40 mg tablet with 240 mL of water (marketed drug)
Pharmacokinetics Parameter	1893.09 ng/mL Standard Deviation 479.62	1907.32 ng/mL Standard Deviation 707.72

SECONDARY outcome

Timeframe: before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration

Area Under Curve from 0 to 24 hours

Outcome measures

Measure	Furosemide 40 mg Tablet n=24 Participants All volunteers received Furosemide 40 mg tablet with 240 mL of water (new and marketed drug)	Lasix® 40 mg Tablet n=24 Participants volunteers received Lasix® 40 mg tablet with 240 mL of water (marketed drug)
Pharmacokinetics Parameter	4938.79 ng*h/mL Standard Deviation 1110.92	4921.94 ng*h/mL Standard Deviation 1279.14

Adverse Events

Furosemide 40 mg Tablet

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Lasix® 40 mg Tablet

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Furosemide 40 mg Tablet n=24 participants at risk volunteers received Furosemide 40 mg tablet with 240 mL of water Furosemide 40 mg: Administered with 240 mL of water	Lasix® 40 mg Tablet n=24 participants at risk volunteers received Lasix® 40 mg tablet with 240 mL of water Lasix® 40 mg Tablet: Administered with 240 mL of water
Nervous system disorders Headache	12.5% 3/24 • Number of events 5 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]	8.3% 2/24 • Number of events 5 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]
Gastrointestinal disorders Polyuria	4.2% 1/24 • Number of events 3 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]	8.3% 2/24 • Number of events 3 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]
Gastrointestinal disorders Frequent urination	8.3% 2/24 • Number of events 3 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]	4.2% 1/24 • Number of events 3 • before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours \[Not Specified\]

Additional Information

Pharma Metric Labs

Pharma Metric Labs, Indonesia

Phone: +62 21 4265310

Email: nabila.sutanto@pharmametriclabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place