Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers

Drug Use Clinical Trial

Official title:

Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982874
• Other study ID #: 447/STD/PML/2019
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: January 29, 2020

Study information

• Verified date: January 2023
• Source: PT. Kimia Farma (Persero) Tbk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 29, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Drug Use

Intervention

Drug:
• Furosemide 40 mg
Administered with 240 mL of water
• Lasix® 40 mg Tablet
Administered with 240 mL of water

Locations

Country	Name	City	State
Indonesia	PT Pharma Metric Labs	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT. Kimia Farma (Persero) Tbk	PT Pharma Metric Labs

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

Brater DC. Diuretic therapy. N Engl J Med. 1998 Aug 6;339(6):387-95. doi: 10.1056/NEJM199808063390607. No abstract available. — View Citation

Chow SC. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304-312. doi: 10.1002/wics.1310. — View Citation

Midha 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. — View Citation

Najib 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 — View Citation

Oh 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. — View Citation

Ponto 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. — View Citation

Shankar 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. — View Citation

Sica DA. Diuretic use in renal disease. Nat Rev Nephrol. 2011 Dec 20;8(2):100-9. doi: 10.1038/nrneph.2011.175. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Ratio of Maximum Concentration	The ratio between test drug and reference drug	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
Primary	Geometric Mean Ratio of Area Under Curve	The ratio between test drug and reference drug	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	Pharmacokinetics Parameter	Maximum plasma concentration	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	Pharmacokinetics Parameter	Area Under Curve from 0 to 24 hours	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