CTRI/2020/01/022665已完成不适用
A randomized, open-label, two-treatment, four-period, two-sequence, single-dose, balanced, crossover, comparative pharmacokinetic study of CPL20090031 Tablets 140mg of Cadila Pharmaceuticals Ltd, India with JANUVIA (Sitagliptin) Tablets 100mg of MSD Pharmaceuticals Limited, India in healthy, adult human subjects under fasting and fed condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To study the comparative pharmacokinetic of CPL-2009-0031 Tablets 140mg of Cadila Pharmaceuticals Ltd., India with JANUVIA (Sitagliptin) Tablets 100mg of MSD Pharmaceuticals Limited, India in healthy, adult human subjects under fasting and fed condition.
研究概览
简要总结
A randomized,open-label, two-treatment, four-period, two-sequence, single-dose, crossover comparativepharmacokinetic study in 16 healthy, adult, human subjects of 18-45 years for comparative evaluation of pharmacokinetic of CPL-2009-0031 Tablets 140mg of Cadila Pharmaceuticals Ltd.,India with JANUVIA (Sitagliptin) Tablets 100mg of MSDPharmaceuticals Limited, India under fasting and fed condition with a washout period of at least 07 days between each consecutive study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy, adult human subject aged from 18 to 45 years (inclusive both).
- •2.Subject’s Body Mass Index (BMI) within normal limit of 18.50-24.90 kg/m2 (inclusive both).
- •3.Willingness to sign statements of written informed consent form (for screening & study related procedures).
- •4.No contraindications with the study medication with any previous medical or surgical history.
- •6.Normal general physical examination.
- •7.Normal ECG finding and vital signs, or abnormalities, which the clinical investigator does not consider a disqualification for participation in the study.
- •8.Investigations with blood sample of the subjects, shows the presence of values which are within acceptable range (as per Annexure-I) 9.Those laboratory values outside acceptable range can be considered clinically insignificant as per PI sole discretion.
- •10.Availability of subject for the entire study period and willingness to adhere to protocol.
- •11.Non-smokers.
- •12.Female counselled for barrier method of contraception.
排除标准
- •1.Institutionalized volunteers.
- •2.Subjects incapable of understanding the informed consent process/ procedure.
- •3.Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements.
- •4.Resting heart rate of >100 beats/min or < 60 beats/min on the screening day.
- •5.History of hypotensive episodes, or systolic blood pressure reading of < 100 mmHg or a diastolic reading of < 60 mmHg at time of general Physical examination.
- •6.History of hypertension, or systolic blood pressure reading of > 140 mmHg or a diastolic reading > 90 mmHg at time of general Physical examination.
- •7.The subject has any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •8.Subject who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical period.
- •9.Subject who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
- •10.The subject with known drug hypersensitivity or idiosyncratic reaction to Sitagliptin, or any related drug or heparin.
- •11.Subjects who are taking terfenadine, astemizole, cisapride, pimozide, ergotamine or dihydroergotamine.
- •12.History of Hepatotoxicity, QT Prolongation, arrhythmia and Clostridium difficile associated Diarrhea.
- •13.History of myasthenia gravis.
- •14.The subject with known history of clinically significant psychiatric or medical diseases will be excluded from the study.
- •15.History of or current alcohol abuse (>600 mL weekly) or history of exposure to other substance of abuse.
- •16.Investigations with blood samples of the subject shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses.
- •17.Positive test for urinary screen testing of drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturate).
- •18.Subject found positive for alcohol breath test.
- •19.Investigations with blood sample of the subjects, shows the presence of values which are clinically significantly different from normal reference range.
- •20.Investigations with urine sample of the subject shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, epithelial cells, glucose and protein (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
- •21.Subject who participated in any other clinical investigation using experimental drug or had bleed more than 300 ml in the past 3 months.
- •22.Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period.
- •25.X-ray chest finding suggesting of any abnormality/ies like cardiomegalia, pneumonia etc.
- •26.Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and /or renal function, that could interfere with the absorption, metabolism, and /or excretion of the study drugs.
- •27.Subjects with a history of cholecystectomy.
- •28.Females who are falling in menstruation period during study.
- •29.Females who are found positive in Urinary Pregnancy Test.
- •30.Females who are lactating their children.
- •31.Females who are using any type of hormonal contraceptives.
结局指标
主要结局
To study the comparative pharmacokinetic of CPL-2009-0031 Tablets 140mg of Cadila Pharmaceuticals Ltd., India with JANUVIA (Sitagliptin) Tablets 100mg of MSD Pharmaceuticals Limited, India in healthy, adult human subjects under fasting and fed condition.
时间窗: Pharmacokinetic blood sample collection at pre-dose (0.00) and 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post-dose.
次要结局
- To evaluate safety parameters, including adverse events and clinical laboratory tests.(Safety assessment till end of study)
研究者
研究点 (1)
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