CTRI/2014/12/005245已完成1 期
A Mono centric, Double Blind, Randomized, Placebo controlled Sequential Phase-I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Nasal Spray of Tapentadol HCl (Torrent Pharmaceuticals Ltd., India) following Single and Multiple Ascending Doses in Healthy Human Volunteers.
Torrent Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1.Sex: male
- •2.Age: 18 - 45 years (inclusive both)
- •3.Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with minimum of 50 kg weight.
- •4.Volunteer willing to provide written informed consent.
- •5.Non-smokers or smoker who smokes less than 10 cigarettes per day.
- •5Non-smokers or smoker who smokes less than 10 cigarettes per day.
排除标准
- •1.Inability to communicate or co-operate.
- •2.Volunteers suffering from any chronic illness such as asthma etc.
- •3.History of pre-existing bleeding disorder.
- •4.Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •5.Clinically significant abnormal ECG or Chest X-ray.
- •6.HIV, HCV, HbsAg positive volunteers.
- •7.History of significant blood loss due to any reason, including blood donation in the past 3 months.
- •8.Participation in any study within past 3 months.
- •9.History of alcohol or drug abuse.
- •10.History of consumption of prescribed medication since last 14 days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
- •11.Positive to Breath alcohol test.
- •12.Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- •13.Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg.
- •14.Persistent pulse rate more than 100/minute.
- •15.Oral temperature more than 98.9°F.
- •16.Respiratory rate more than 20/minute
- •17.History of any drug allergy.
- •18.History of kidney or liver dysfunction within last 6 months.
- •19.Volunteers suffering from any psychiatric (acute or chronic) disorder.
- •20.Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- •21.H/O current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray.
- •22.H/O use of any medication by nasal route within past 72 hours of the study.
- •23.H/O tobacco sniffing.
- •24.H/O any chronic nasal conditions i.e., atrophic rhinitis, nasal polyp etc which can interfere with the absorption of the drug.
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