Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
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.
详细描述
The study was conducted following an oral administration of one tablet of the test drug (3 mg Glimepiride Tablet) or one tablet of the reference drug (3 mg Amaryl® Tablet ). Blood samples were drawn before dosing (0 h) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration. The entire subjects were given 60 mL of 20% glucose solution to minimize hypoglycemic effects at 15, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 and 4 hours after drug administration. Following a washout period of one week, this procedure was repeated using the alternate drug. The plasma concentrations of glimepiride were determined by means of LC-MS/MS system. The LLOQ is 1.99 ng/mL of glimepiride. The pharmacokinetic parameters used in this study were area under the concentration-time curve of glimepiride from time zero to 30 hours (AUCt), area under the concentration-time curve from time zero to infinite (AUCinf), maximum concentration (Cmax), time required to reach the maximum concentration (tmax) and the elimination half life (t½).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Glimepiride 3 mg Tablet
Participants received Glimepiride 3 mg Tablet with 240 mL of 20% glucose solution
干预措施: Glimepiride (Drug)
Amaryl® 3 mg tablet
Participants received Amaryl® 3 mg tablet (Glimepiride 3 mg) with 240 mL of 20% glucose solution
干预措施: Amaryl® (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
90% Confidence Interval
Area Under Curve from 0 to 30 hours (AUCt)
时间窗: before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration
90% Confidence Interval
次要结局
- Maximum plasma concentration (Cmax)(before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration)
- Area Under Curve from 0 to 30 hours (AUCt)(before dosing (0 hour) and at 15, 30, 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, and 30 hours after drug administration)