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

Sponsor
PT. Kimia Farma (Persero) Tbk (Industry)
Overall Status
Completed
CT.gov ID
NCT04982874
Collaborator
PT Pharma Metric Labs (Industry)
24
1
2
1.5
15.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Furosemide 40 mg
  • Drug: Lasix® 40 mg Tablet
N/A

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

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 conditionrandomized, 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 (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers
Actual Study Start Date :
Dec 13, 2019
Actual Primary Completion Date :
Jan 17, 2020
Actual Study Completion Date :
Jan 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Furosemide 40 mg tablet

volunteers received Furosemide 40 mg tablet with 240 mL of water

Drug: Furosemide 40 mg
Administered with 240 mL of water

Active Comparator: Lasix® 40 mg Tablet

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

Drug: Lasix® 40 mg Tablet
Administered with 240 mL of water
Other Names:
  • Furosemide 40 mg
  • Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Ratio [1 month]

      The ratio between test drug and reference drug

    2. 90% confidence intervals [1 month]

      The two products are considered bioequivalent when the 90% confidence intervals of the furosemide geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax.

    Secondary Outcome Measures

    1. Pharmacokinetics parameter [1 month]

      Maximum plasma concentration (Cmax)

    2. Pharmacokinetics parameter [1 month]

      Area Under Curve from 0 to 24 hours (AUCt)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PT Pharma Metric Labs Jakarta Pusat DKI Jakarta Indonesia 10520

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Frans D Suyatna, PT Pharma Metric Labs
    • Study Director: I Gusti Putu Bagus Diana Virgo, PT Pharma Metric Labs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PT. Kimia Farma (Persero) Tbk
    ClinicalTrials.gov Identifier:
    NCT04982874
    Other Study ID Numbers:
    • 447/STD/PML/2019
    First Posted:
    Jul 29, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PT. Kimia Farma (Persero) Tbk
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2021