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

NCT04982874 | Completed Results DMC

• 1 other identifier: 447/STD/PML/2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Use

Keywords

bioequivalence; furosemide; Indonesian healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Pharmacokinetics Parameter

  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

  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

Study Arms (2)

Furosemide 40 mg tablet

EXPERIMENTAL

volunteers received Furosemide 40 mg tablet with 240 mL of water

Drug: Furosemide 40 mg

Lasix® 40 mg Tablet

ACTIVE COMPARATOR

volunteers received Lasix® 40 mg tablet with 240 mL of water

Drug: Lasix® 40 mg Tablet

Interventions

Furosemide 40 mg DRUG

Administered with 240 mL of water

Furosemide 40 mg tablet

Lasix® 40 mg Tablet DRUG

Administered with 240 mL of water

Also known as: Furosemide 40 mg

Lasix® 40 mg Tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Kimia Farma (Persero) Tbk: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta Pusat, DKI Jakarta, 10520, Indonesia

Location

Related Publications (8)

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

  PMID: 25215170 RESULT

• 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.

  PMID: 26240596 RESULT

• 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.361.

  PMID: 12973821 RESULT

• 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.

  PMID: 12473535 RESULT

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

  PMID: 9691107 RESULT

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

  PMID: 22183505 RESULT

• 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.

  PMID: 2185908 RESULT

• 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.

  PMID: 19806461 RESULT

MeSH Terms

Interventions

Furosemide; Tablets

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Pharma Metric Labs
• Organization: Pharma Metric Labs, Indonesia

nabila.sutanto@pharmametriclabs.com

+62 21 4265310

Study Officials

• Frans D Suyatna

  PT Pharma Metric Labs

  PRINCIPAL INVESTIGATOR

• I Gusti Putu Bagus Diana Virgo

  PT Pharma Metric Labs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 29, 2021
• Study Start: December 13, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 29, 2020
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-01

Locations

ID (1)