NCT00973232已完成1 期
A Single-Centre, Open-Label, Randomised Study to Compare the Single Dose (Including the Effect of Food) and Multiple Dose Pharmacokinetic Profiles of Acetram Contramid® BID Tablets vs the Immediate-Release Tablet Reference Products Zaldiar® and Ultracet®
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Rate and extent of exposure
研究概览
简要总结
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.
详细描述
- To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and bioavailability of DDS-06C tablets with the immediate-release tablet reference products Zaldiar® and Ultracet®.
- To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following administration of a single oral dose.
- To monitor and record all adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2
- •Healthy as determined by pre-study medical history, physical examination and 12-lead ECG
- •Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator
- •Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
- •Negative for drugs of abuse and alcohol at screening and admission
- •Non-smokers for at least 3 months preceding screening
- •If female, were not currently pregnant or breast feeding and were using medically acceptable methods of contraception and if male, were themselves and their female partners using medically acceptable methods of contraception
- •Able and willing to give written informed consent.
排除标准
- •Subjects who did not conform to the above inclusion criteria
- •Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception
- •Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- •Clinically relevant surgical history
- •Clinically relevant family history
- •History of relevant atopy
- •History of relevant drug hypersensitivity
- •History of alcoholism
- •History of drug abuse
- •Male subjects who consumed more than 21 units of alcohol a week and female subjects who consumed more than 14 units of alcohol a week
- •Significant infection or known inflammatory process on screening
- •Acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
- •Acute infection such as influenza at the time of screening or admission
- •Use of prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
- •Use of over-the-counter medication excluding routine vitamins but including mega dose vitamin therapy within 14 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
- •Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing
- •Donation or receipt of any blood or blood products within the previous 3 months prior to first dosing
- •Vegetarians, vegans or having medical or cultural dietary restrictions.
- •Inability to communicate reliably with the Investigator.
- •Subjects who were unlikely to co-operate with the requirements of the study
研究组 & 干预措施
Part A, Arm A
Experimental
干预措施: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) (Drug)
Part A, Arm B
Experimental
干预措施: DDS-06C (650 mg acetaminophen and 75 mg tramadol) (Drug)
Part A, Arm C
Active Comparator
干预措施: Zaldiar® (Drug)
Part A, Arm D
Active Comparator
干预措施: Ultracet® (Drug)
Part B, Arm E
Experimental
干预措施: Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions (Drug)
Part B, Arm G
Active Comparator
干预措施: Ultracet®, multiple doses, (fed & fasting) (Drug)
结局指标
主要结局
Rate and extent of exposure
时间窗: 0 to 36 hours post dose
次要结局
未报告次要终点
研究者
研究点 (1)
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