Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

• Status: Completed
• Trial end date: 2021-01-06
• Target enrollment: 0
• Participant gender: All

Summary

The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT. Aventis Indonesia Pharma, Indonesia.

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

Details

• Lead Sponsor: PT Harsen Laboratories
• Collaborator: PT Pharma Metric Labs
• Treatments: Glimepiride

Criteria

Inclusion Criteria:

• healthy male and female

• had read the subject information and signed informed consent documents

• were age between 18 to 55 years

• had body mass index between 18 to 25 kg/m2

• had a normal electrocardiogram

• had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)

• had normal heart rate (ranged between 60 to 100 bpm)

• have no significant disease in medical history; have no significant abnormal values in laboratory and physical examination during screening

• had acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

• Pregnant and/or nursing woman.

• Those with a history of contraindication or hypersensitivity to glimepiride, other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction.

• Those with a history or presence of medical condition which might significantly influence the pharmacokinetics 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 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 had participated in any clinical study within 3 months prior to the study (< 90 days).

• Those who donated or lost 300 mL (or more) of blood within 3 months prior to the study.

• Those who smoked more than 10 cigarettes a day

• Those with a history of travelling to another city within the last 14 days

• Those with a history of direct contact with a COVID-19 positive person in the subject's neighborhood

• Those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea within the last 14 days

• Those who reactive to anti SARS CoV-2 test

• Those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).

• Those with a history of drug or alcohol abused within 12 months prior to screening for this study

• Those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.