Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers
Open, Comparative, Randomized, Crossover, Single Dose Bioequivalence Study of Metformin 500 mg Prolonged Release Tablets (JSC Farmak, Ukraine) vs Glucophage® XR 500 mg Prolonged Release Tablets in Healthy Subjects Under Fasting Conditions.
研究概览
地位
条件
详细说明
An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in Healthy, Adult Male and Female Subjects under Fasting Conditions.
During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0 hours after Investigational Medicinal Product (IMP) administration.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
-
Prague、捷克语、10200
- QUINTA-ANALYTICA s.r.o.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy males and non-pregnant and no breast-feeding females (must have a negative pregnansy test result prior to dosing). Caucasian race.
- Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
- Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive and body weight between 50 kg and 100 kg (on the day of screening).
- Subject was available for the whole study and has provided his/her written informed consent.
- Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator.
- All laboratory screening results within the normal range. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Clinical Investigator.
- Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
Exclusion Criteria:
- Known cardiovascular disease, history of hypotension.
- Factors in the subject's history that may predispose to ketoacidosis (including pancreatic insulin deficiency, history of pancreatitis, caloric restriction disorders, restricted food intake, alcohol abuse).
- Gastrointestinal, renal or hepatic diseases and/or pathological findings present or in history, which might interfere with the drug pharmacokinetics.
- Glucose level out of the limit 3.3 mmol/L - 5.5 mmol/Lat screening, as determined by screening clinical laboratory evaluations.
- Previous liver disease or clinically significant elevations in serum transaminases at the screening.
- Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug's safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
- History of kidney disease and with impaired renal function.
- History of severe allergy or allergic reactions to the study IMP, its excipients or related drugs.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Any significant clinical abnormality including Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV. (On screening).
- Positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
- Positive results of drugs of abuse in urine at screening and at check-in.
- Positive result of alcohol breath test at screening and at check-in.
- Positive result of urine cotinine test at screening and at check-in.
- Serious mental disease and/or inability to cooperate with clinical team.
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic blood pressure (BP) and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
- Body ear temperature is out of the range of 35.7 - 37.3°C at screening and at check-in.
- Orthostatic hypotension during the screening procedure.
- Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse.
- Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing.
- Use of any prescription medication for a period of 28 days before the first dosing.
- Use of any OTC (over-the-counter) medication including vitamins, herbal medications and food supplements less than 14 days before the first dosing.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin piercing within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
- Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
- Anemia, haemoglobin below 120 g/L for women and 130 g/L for men at screening.
- Less than 30 days between exit procedure in previous study and the first dosing in in this study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Treatment A
Metformin 500 mg Prolonged Release Tablets (JSC Farmak, Ukraine)
|
One tablet of the Test product was administered orally with 240 mL of water.
其他名称:
|
有源比较器:Treatment B
Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
|
One tablet of Reference (R) Product was administered orally with 240 mL of water.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
AUC0-t
大体时间:up to 36 hours post-administration
|
Area under the plasma drug concentration versus time curve
|
up to 36 hours post-administration
|
Cmax
大体时间:up to 36 hours post-administration
|
Maximum plasma concentration observed.
|
up to 36 hours post-administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
最高温度
大体时间:给药后最多 36 小时
|
最大血浆药物浓度的时间。
|
给药后最多 36 小时
|
AUCres
大体时间:给药后最多 36 小时
|
剩余面积
|
给药后最多 36 小时
|
AUC(0-∞)
大体时间:up to 36 hours post-administration
|
Area under the plasma drug concentration versus time curve from time zero to infinity
|
up to 36 hours post-administration
|
AUC(0-12h)
大体时间:from time zero to time 12 hours after dosing.
|
The area under the plasma drug concentration versus time curve calculated from time zero to time 12 hours after dosing.
|
from time zero to time 12 hours after dosing.
|
AUC(12h-t)
大体时间:from time 12 hours after dosing up to 36 hours post-administration
|
The area under the plasma drug concentration versus time curve calculated from time 12 hours after dosing to time of the last sample above LLOQ
|
from time 12 hours after dosing up to 36 hours post-administration
|
AUC(0-24h)
大体时间:from time zero to time 24 hours after dosing
|
The area under the plasma drug concentration versus time curve calculated from time zero to time 24 hours after dosing.
|
from time zero to time 24 hours after dosing
|
λz
大体时间:up to 36 hours post-administration
|
Apparent first-order elimination
|
up to 36 hours post-administration
|
t1/2
大体时间:up to 36 hours post-administration
|
The elimination or terminal half-life
|
up to 36 hours post-administration
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.