TCTR20220629003尚未招募1 期
An open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose, crossover oral bioequivalence study of Linagliptin Tablets 5 mg of Dr.Reddy Laboratories Limited,India comparing TRAJENTA(Linagliptin) Film-coated Tablet 5 mg of Boehringer Ingelheim(Thai) Ltd.,Bangkok,Thailand in healthy adult human subjects under fasted conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Willingness to provide written informed consent prior to participate in the study.
- •2.Healthy Thai subjects are between 18 to 55 years of age.
- •3.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
- •4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects safety after the completion of the study.
- •5.Negative urine pregnancy test for women and no breast-feeding.
- •6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
排除标准
- •1.History or evidence of allergy or hypersensitivity to Linagliptin or any related drugs or any of the excipients of this product.
- •2.Subject with B.P. is Systolic B.P < 90, >,= 140 mm/Hg, Diastolic B.P < 60, >,= 90 mm/Hg, pulse rate > 100 beats per minute.
- •3.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- •4.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- •5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- •6.Positive of hepatitis B or C virus or HIV.
- •7.Have more than one abnormal ECG, which is considered as clinically significant. *
- •8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, gastrointestinal, immunological, dermatological, metabolic disease, hypertension or glaucoma.
- •9.History or presence of pancreatitis or rhabdomyolysis.
- •10.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
- •11.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
- •12.History or presence of psychiatric disorder.
- •13.History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •14.History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
- •15.High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •16.History of pomelo or grapefruit juice or related products consumption and cannot stop for at least 72.00 hours before the study drug administration and until the completion of each period of the study.
- •17.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
- •18.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to the study drug administration and until the completion of each period of the study.
- •19.History of difficulty in accessibility of veins in left and right arm.
- •20.Blood donation (one unit or 450 mL) within the past 3 months before the study.
- •21.Participation in any clinical study within the past 3 months before the study.
- •22.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- •(* Depend on decision of principal investigator and/or clinical investigator)
研究者
相似试验
已完成
不适用
bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tabletCTRI/2022/03/041021aboratorios LETI SAV23
已完成
不适用
A bio-equivalence study to characterize the rate and extent of absorption of Vinorelbine after oral administration of the sponsorâ??s test product Vinorelbine soft capsule 60 mg/m2 relative to that of the reference product 60 mg/m2 of NAVELBINE® soft capsule in adult patients.CTRI/2016/04/006892otus Pharmaceutical Co Ltd64
尚未招募
不适用
Comparative bioavailability study of Test product Alogliptin and Pioglitazone tablets 12.5 mg/45 mg compared with the reference product of Oseni (alogliptin and pioglitazone) tablets 12.5 mg/ 45 mg, in healthy, adult, human subjects, under fed conditions.CTRI/2019/04/018646Indoco Remedies Limited
进行中（未招募）
Unknown
Bioequivalence study of Esomeprazole 20 mg Naproxen 500 mg Delayed Release Tablets in healthy adult human subjects under fasting conditioCTRI/2023/04/051767Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited)
已完成
不适用
Bioequivalence study of Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) in healthy, adult, human subjects.CTRI/2023/02/049405The ACME Laboratories Ltd24