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

• Status: Completed
• Trial end date: 2020-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PT. Kimia Farma (Persero) Tbk
• Collaborator: PT Pharma Metric Labs
• Treatments: Furosemide

Criteria

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