Drug UseNCT04982874
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
A study testing Furosemide 40 mg and Lasix® 40 mg Tablet in people with Drug Use, run by PT. Kimia Farma (Persero) Tbk at 1 site in Indonesia.
Trial summary
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Furosemide 40 mg and Lasix® 40 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Dec 2019to 29 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have read the subject information and signed informed consent documents
- age 18 - 55 years
- body mass index between 18-25 kg/m2
- have a normal electrocardiogram
- blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
- heart rate within normal range (60-100 bpm)
- with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
- acceptance to use protection (condom) during intercourse with their spouse throughout the study
Who cannot join
- those who are pregnant and/or nursing women
- those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction
- those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
- those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities
- those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day
- those who have participated in any clinical study within 3 months prior to the study (< 90 days)
Show all 11Show fewer
- those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study
- those who smoke more than 10 cigarettes a day
- those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential)
- those with a history of drug or alcohol abuse within 12 months prior to screening for this study
- those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
Read the detailed description
Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix® 40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation
- Conditions
- Drug Use
- Being tested
- Furosemide 40 mg, Lasix® 40 mg Tablet
- Keywords
- bioequivalence, furosemide, Indonesian healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 40 mgDrug
Administered with 240 mL of water
Lasix® 40 mg TabletDrug
Also called Furosemide 40 mg
Administered with 240 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Furosemide 40 mg tablet | Experimental | volunteers received Furosemide 40 mg tablet with 240 mL of water Receives: Drug: Furosemide 40 mg |
| Lasix® 40 mg Tablet | Active comparator | volunteers received Lasix® 40 mg tablet with 240 mL of water Receives: Drug: Lasix® 40 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio of Maximum Concentration
The ratio between test drug and reference drug
Measured: 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
Geometric Mean Ratio of Area Under Curve
The ratio between test drug and reference drug
Measured: 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
Secondary outcomes (2)
Pharmacokinetics Parameter
Maximum plasma concentration
Measured: 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
Pharmacokinetics Parameter
Area Under Curve from 0 to 24 hours
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start13 Dec 2019
- Primary completion17 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, single blind, single dose, 2-period, cross-over design with one week washout period between each treatment in 24 healthy volunteers beneath fasting condition
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Kimia Farma (Persero) Tbk
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Responsible party
- Sponsor
- Investigators
- Frans D Suyatna, Principal investigator, PT Pharma Metric LabsI Gusti Putu Bagus Diana Virgo, Study director, PT Pharma Metric Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982874
- Sponsor's protocol ID
- 447/STD/PML/2019
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2021
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chow SC. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304-312. doi: 10.1002/wics.1310.
PubMed 25215170Oh SW, Han SY. Loop Diuretics in Clinical Practice. Electrolyte Blood Press. 2015 Jun;13(1):17-21. doi: 10.5049/EBP.2015.13.1.17. Epub 2015 Jun 30.
PubMed 26240596Najib N, Idkaidek N, Beshtawi M, Bader M, Admour I, Alam SM, Zaman Q, Dham R. Bioequivalence evaluation of two brands of furosemide 40 mg tablets (Salurin and Lasix) in healthy human volunteers. Biopharm Drug Dispos. 2003 Sep;24(6):245-9. doi: 10.1002/bdd.361.
PubMed 12973821Shankar SS, Brater DC. Loop diuretics: from the Na-K-2Cl transporter to clinical use. Am J Physiol Renal Physiol. 2003 Jan;284(1):F11-21. doi: 10.1152/ajprenal.00119.2002.
PubMed 12473535Brater DC. Diuretic therapy. N Engl J Med. 1998 Aug 6;339(6):387-95. doi: 10.1056/NEJM199808063390607. No abstract available.
PubMed 9691107Sica DA. Diuretic use in renal disease. Nat Rev Nephrol. 2011 Dec 20;8(2):100-9. doi: 10.1038/nrneph.2011.175.
PubMed 22183505Ponto LL, Schoenwald RD. Furosemide (frusemide). A pharmacokinetic/pharmacodynamic review (Part I). Clin Pharmacokinet. 1990 May;18(5):381-408. doi: 10.2165/00003088-199018050-00004.
PubMed 2185908Midha KK, McKay G. Bioequivalence; its history, practice, and future. AAPS J. 2009 Dec;11(4):664-70. doi: 10.1208/s12248-009-9142-z. Epub 2009 Oct 6. No abstract available.
PubMed 19806461
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04982874
- Acronym / sponsor ID
- 447/STD/PML/2019
- Conditions
- Drug Use
- Keywords
- bioequivalence, furosemide, Indonesian healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PT. Kimia Farma (Persero) TbkIndustry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
Detailed description
Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix® 40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, single blind, single dose, 2-period, cross-over design with one week washout period between each treatment in 24 healthy volunteers beneath fasting condition
| Arm | Type | Receives |
|---|---|---|
| Furosemide 40 mg tablet | Experimental | Drug: Furosemide 40 mgvolunteers received Furosemide 40 mg tablet with 240 mL of water |
| Lasix® 40 mg Tablet | Active comparator | Drug: Lasix® 40 mg Tabletvolunteers received Lasix® 40 mg tablet with 240 mL of water |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- have read the subject information and signed informed consent documents
- age 18 - 55 years
- body mass index between 18-25 kg/m2
- have a normal electrocardiogram
- blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
Key exclusion criteria (11 listed)
- those who are pregnant and/or nursing women
- those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction
- those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
- those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities
- those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide 40 mgAdministered with 240 mL of water | Drug | Furosemide 40 mg tablet |
| Lasix® 40 mg TabletAlso: Furosemide 40 mgAdministered with 240 mL of water | Drug | Lasix® 40 mg Tablet |
Primary outcome
Geometric Mean Ratio of Maximum Concentration
Time frame: 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
Geometric Mean Ratio of Area Under Curve
Time frame: 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
2 secondary outcomes
Pharmacokinetics Parameter
Time frame: 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
Pharmacokinetics Parameter
Time frame: 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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25215170Chow SC. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304-312. doi: 10.1002/wics.1310.
- Results publication: PubMed 26240596Oh SW, Han SY. Loop Diuretics in Clinical Practice. Electrolyte Blood Press. 2015 Jun;13(1):17-21. doi: 10.5049/EBP.2015.13.1.17. Epub 2015 Jun 30.
- Results publication: PubMed 12973821Najib N, Idkaidek N, Beshtawi M, Bader M, Admour I, Alam SM, Zaman Q, Dham R. Bioequivalence evaluation of two brands of furosemide 40 mg tablets (Salurin and Lasix) in healthy human volunteers. Biopharm Drug Dispos. 2003 Sep;24(6):245-9. doi: 10.1002/bdd.361.
- Results publication: PubMed 12473535Shankar SS, Brater DC. Loop diuretics: from the Na-K-2Cl transporter to clinical use. Am J Physiol Renal Physiol. 2003 Jan;284(1):F11-21. doi: 10.1152/ajprenal.00119.2002.
- Results publication: PubMed 9691107Brater DC. Diuretic therapy. N Engl J Med. 1998 Aug 6;339(6):387-95. doi: 10.1056/NEJM199808063390607. No abstract available.
- Results publication: PubMed 22183505Sica DA. Diuretic use in renal disease. Nat Rev Nephrol. 2011 Dec 20;8(2):100-9. doi: 10.1038/nrneph.2011.175.
- Results publication: PubMed 2185908Ponto LL, Schoenwald RD. Furosemide (frusemide). A pharmacokinetic/pharmacodynamic review (Part I). Clin Pharmacokinet. 1990 May;18(5):381-408. doi: 10.2165/00003088-199018050-00004.
- Results publication: PubMed 19806461Midha KK, McKay G. Bioequivalence; its history, practice, and future. AAPS J. 2009 Dec;11(4):664-70. doi: 10.1208/s12248-009-9142-z. Epub 2009 Oct 6. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans D Suyatna principal investigator
PT Pharma Metric Labs
I Gusti Putu Bagus Diana Virgo study director
PT Pharma Metric Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide 40 mg and Lasix® 40 mg Tablet in people with Drug Use, run by PT. Kimia Farma (Persero) Tbk at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Ratio of Maximum Concentration (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982874, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.