CTRI/2023/01/048758已完成不适用
An open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, truncated, crossover oral bioequivalence study between the Test Product, Trelagliptin 100 mg Tablets (Zuventus Healthcare Ltd., India) and the Reference Product, Zafatek® (Trelagliptin 100 mg) tablets (Takeda Pharmaceutical Company Limited, Japan) in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To demonstrate the bioequivalence between Trelagliptin 100 mg Tablets (Zuventus Healthcare Ltd., India) and the Reference Product, Zafatek® (Trelagliptin 100mg) tablets (Takeda Pharmaceutical Company Limited, Japan) in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
Trelagliptinis an oral long-acting dipeptidyl peptidaseâ€4 (DPPâ€4) inhibitor withonceâ€weekly dosing in type 2 Diabetes Mellitus (T2DM). This study is designedto evaluate the bioequivalence between the Test product, Trelagliptin 100 mgtablets of Zuventus Healthcare Limited, India and the Reference product, Zafatek®(Trelagliptin 100mg) tablets of Takeda Pharmaceutical Company Limited, Japan inhealthy, adult, human subjects under fasting conditions
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
- •Healthy human subjects between 18-45 years of age (including both)
- •Subjects able to communicate effectively.
- •HbA1c levels (As per lab reference ranges including both normal and prediabetic individuals).
- •Volunteers who give consent by signing the informed consent form after understanding the study-related information about the nature, risk, and scope of the clinical study as well as the expected adverse effects of the drug.
- •Volunteers who are non-smokers will be included in the study.
- •Body mass index in the range of 18.5 to 29.9 kg/m² (weight should be ≥ 50 Kg).
- •Normal 12-lead ECG
- •Normal chest X-ray
- •Normal laboratory parameters
- •Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL
- •Subject willing to abstain from all kinds of alcoholic beverages, pan or pan masala, gutkha, masala (containing betel nut), having caffeine/xanthine containing foods or beverages and grapefruit or citrus containing foods or juices from at least 48.00 hours prior to admission until the last blood sample collection in each study period.
- •Female subjects: • of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
- •â€¢ Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •Volunteers having contraindication or hypersensitivity (e.g., anaphylaxis) to Trelagliptin or related class of drugs and any of its ingredients.
- •History or presence of significant seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
- •History or evidence of Lactic Acidosis.
- •History or evidence of Hypoglycemia/recurrent hypoglycemic attacks.
- •History of insulin dependent diabetes.
- •History or evidence of exfoliative dermatitis, Stevens.
- •Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •Any known enzyme inducing or inhibiting drug taken within 14 days before each study period.
- •Participation in a drug research study within 90 days prior to dosing of this study.
- •Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug administration.
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •History of addiction to any recreational drug or drug dependence.
- •An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each period.
- •Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
- •Positive results for alcohol consumption during the admission of each study period.
- •History of pre-existing bleeding disorder.
- •Difficulty with donating blood.
- •Difficulty in swallowing oral solid investigational products.
- •Blood pressure on the day of admission of each study period a. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
- •Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study or at least 5 half-lives of the compound whichever period is longer prior to study admission.
- •History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
- •Females Subjects: ➢ Female subjects demonstrating a positive serum pregnancy test. ➢ Female volunteer who is pregnant or currently breast-feeding. ➢ Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
结局指标
主要结局
To demonstrate the bioequivalence between Trelagliptin 100 mg Tablets (Zuventus Healthcare Ltd., India) and the Reference Product, Zafatek® (Trelagliptin 100mg) tablets (Takeda Pharmaceutical Company Limited, Japan) in healthy, adult, human subjects under fasting conditions.
时间窗: Pharmacokinetic parameters Cmax, AUC0-72 for Trelagliptin from the test product to that of reference products will be assessed on pre-dose (00.00 hour) and at 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose in each study period.
次要结局
- To monitor the safety, tolerability of single dose of Trelagliptin 100 mg tablets.(Admission in the study to last study sample collection)
研究者
研究点 (1)
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