NCT05337969已完成不适用
Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 850/ 50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/850mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Cmax of Vildagliptin and Metformin for the test and reference products
研究概览
简要总结
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/850mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects aged between 18 and 45 years (both inclusive).
- •Subjects' weight within the normal range according to normal values for the Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- •Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •Subjects having clinically acceptable chest X-Ray (PA view).
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- •Subjects having negative alcohol breath test.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •No history or presence of smoking.
- •No history or presence of alcoholism and drug of abuse.
排除标准
- •Hypersensitivity to Vildagliptin or Metformin or related class of drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer or basal or squamous cell carcinoma.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Use of any prescribed medication during the last one month or OTC medication during last two weeks prior to Dosing in Period
- •Major illness during 3 months before screening.
- •Donation of blood in the past 3 months before screening.
- •Participation in drug research study within past 3 months.
- •Consumption of grapefruit juice within 72.00 hours prior to dosing in Period 01 and xanthine-containing products, tobacco containing products or alcohol within 48.00 hours prior to dosing in Period
- •Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
- •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
研究组 & 干预措施
Metformin and Vildagliptin 850/50 mg Tablet
Experimental
1 tablet of Metformin and Vildagliptin 850/50 mg as single-dose administration
干预措施: Metformin and Vildagliptin 850/50 mg (Drug)
EUCREAS® 50/850mg Tablet
Active Comparator
1 tablet of EUCREAS® 50/850mg (each film-coated tablet contains Vildagliptin 50mg and Metformin hydrochloride 850mg) as single-dose administration
干预措施: Metformin and Vildagliptin 850/50 mg (Drug)
结局指标
主要结局
Cmax of Vildagliptin and Metformin for the test and reference products
时间窗: up to 24 hours
The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of Vildagliptin and Metformin for the test and the reference products
时间窗: up to 24 hours
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
次要结局
- Tmax of Vildagliptin and Metformin for the test and the reference products(up to 24 hours)
- T1/2 of Vildagliptin and Metfomin for the test and the reference products(up to 24 hours)
- AUC0-∞ of Vildagliptin and Metformin for the test and the reference products(up to 24 hours)
- Kel of Vildagliptin and Metformin for the test and the reference products(up to 24 hours)
- Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol(through study completion, an average of 1 month)
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