Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers

Bial - Portela C S.A.1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2006年9月最近更新: 2017年8月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 16
试验地点: 1
主要终点: Mean Cmax of S-warfarin

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether multiple-dose administration of nebicapone affects the pharmacokinetics of warfarin.

详细描述

Study design and methodology:

This was a single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study consisted of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects received nebicapone 200 mg thrice-daily (tid) for 9 days, and a warfarin 25 mg single-dose concomitantly with the morning dose of nebicapone on Day 4. In the other period, a warfarin 25 mg single-dose was administered alone. Warfarin pharmacokinetic and pharmacodynamic profiles were characterised following warfarin dosing.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:
•Male or female subjects aged between 18 and 45 years, inclusive.
•Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
•Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
•Clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
•Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
•Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
•Non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.
•Able and willing to give written informed consent.
•(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
•(If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

排除标准

•Subjects were not eligible for entry into the study if they fulfilled the following exclusion criteria:
•Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
•Clinically relevant surgical history.
•Personal or family history of haemostatic disorder.
•Personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
•Any abnormality in the coagulation tests.
•Any abnormality in the liver function tests.
•A history of relevant atopy or drug hypersensitivity.
•History of alcoholism or drug abuse.
•Consumed more than 14 units of alcohol a week.
•Significant infection or known inflammatory process at screening or admission to each treatment period.
•Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
•Had used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
•Had previously received BIA 3-
•Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
•Had participated in more than 2 clinical trials within the 12 months prior to screening.
•Had donated or received any blood or blood products within the 3 months prior to screening.
•Vegetarians, vegans or had medical dietary restrictions.
•Cannot communicate reliably with the investigator.
•Unlikely to co-operate with the requirements of the study.
•Unwilling or unable to gave written informed consent.
•(If female) She was pregnant or breast-feeding.
•(If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.

研究组 & 干预措施

Nebicapone plus warfarin

Experimental

BIA 3-202 200 mg tid + Warfarin 25 mg

干预措施: BIA 3-202 (Drug)

Nebicapone plus warfarin

Experimental

BIA 3-202 200 mg tid + Warfarin 25 mg

干预措施: warfarin (Drug)

Warfarin

Experimental

Warfarin 25 mg

干预措施: warfarin (Drug)