Pharmacokinetics and bioequivalence (BE) study of a new branded generic of Etoricoxib (ETO) tablets among healthy volunteers

/A0 个研究点目标入组 24 人开始时间: 2021年7月14日最近更新: 2024年8月19日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

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 45 Years（—）
性别: All

入选标准

•1.Human subjects aged from 18 to 45 years inclusive, 2.BMI range from 18.5 to 30.0 kg/m2 inclusive with the body weight Not Less Than 45 kgs, 3.Subjects who have Hemoglobin value Not Less Than 12.5 g/dL, 4.Normal vital signs (blood pressure, pulse rate and body temperature), 5.Normal medical and surgical history as approved by the physician or principal investigator prior to start of the study, 6.Normal functioning cardiovascular, respiratory, gastrointestinal, nervous system,musculoskeletal, vascular, genitourinary, endocrine/metabolic systems, 7.No history of dehydration from diarrhoea, vomiting, excess sweating or any other reason within a period of 24.00 hours prior to study check-in, 8.History of non-smoking, 9.Normal nail buds without clubbing, 10.Subjects with normal laboratory investigations (if any subject is enrolled into the study despite having a measurement outside the normal laboratory range, the physician should have a clearly documented and medically rigorous justification for making that exception), 11.Normal 12-lead electrocardiogram (ECG), 12.Normal chest X-Ray (P/A view).

排除标准

•1.Contraindications or hypersensitivity to Etoricoxib and any of its excipients, 2.History or presence of any disease in the recent past (gastric, renal, respiratory, cardiac,neurological etc.) regarded by the physician as clinically important, 3.History or presence of significant alcoholism or drug abuse in the past year, 4.History or presence of significant asthma, urticaria or other allergic reactions, 5.History or presence of Active peptic ulceration or active gastro-intestinal (GI) bleeding, 6.History of usage of acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors in recent past, 7.History or presence of bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema,urticaria, or allergic-type reactions, 8.History or presence of inflammatory bowel disease, congestive heart failure, Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, 9.History of difficulty in donating blood or difficulty in accessing veins, 10.Difficulty in swallowing Investigational products, 11.Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg during Period-01 check-in, 12.Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg during Period-01 check-in, 13.Pulse rate less than 60/minute or more than 100/minute during Period-01 check-in, 14.Use of any prescribed medication during last two weeks or OTC medicines or herbal medicinal products during the last one week preceding the first period check-in until completion of the study, 15.Major illness during 3 months before screening, 16.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening, 17.Participation in a drug research study within past 3 months, 18.Donation of blood in the past 3 months before screening, 19.Refusal to abstain from water for at least 01.00 hour prior to dosing and for at least
•01.00 hour post-dose, 20.Refusal to abstain from food for at least 10.00 hours before scheduled time for dosing and for at least 04.00 hours post-dose, 21.Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee,tea, carbonated drinks, chocolate) and grapefruit or its juice from 48.00 hours prior to the first period check-in until last sample collection, 22.Presence of disease markers hepatitis B & C virus and VDRL, 23.HIV positive, 24.Positive alcohol breath test at the time of check-in, 25.Positive urine test of drugs of abuse made at check-in, 26.Evidence of an uncooperative attitude

研究者

发起方

相似试验

已完成

不适用

Bioequivalence (BE) Study of a New Branded Generic of Moxifloxacin TabletsMoxifloxacin could potentially cause nausea&#44diarrhea&#44headache&#44vomiting&#44dizziness&#44nervousness&#44agitation and nightmares. As for the safety of the formulation&#44no adverse event was reported based oMoxifloxacinbioequivalencepharmacokinetics

JPRN-jRCT2080223335Meiji Seika Pharma Co., Ltd.180

未知

1 期

DMB-3111 phase IHealthy volunteers

JPRN-jRCT2080222436Meiji Seika Pharma Co., Ltd.70

暂停

不适用

Bioequivalence Study Comparing Generic to Reference Liposome-Encapsulated Doxorubicin Hydrochloride

CTRI/2019/05/019051Aine Cunningham

已完成

1 期

A pharmacokinetic study to assess the comparative bioavailability of 17-B-estradiol from Metered-Dose Transdermal Sprays (MDTS) and Estraderm 50 patches as hormone replacement therapy in postmenopausal women.Hormone replacement therapy in postmenopausal womenReproductive Health and Childbirth - Menstruation and menopause

ACTRN12605000468628FemPharm Pty Ltd and/or Acrux DDS Pty Ltd12