CTRI/2012/03/002495Other1 期
A randomized, double-blind, placebo- and active-controlled, cross over, single escalating dose study to assess the safety, tolerability and pharmacokinetics of compound G44 in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 48
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.Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- •2.Healthy male and female subjects, 18 to 45 years of age inclusive, subjects having weight at least 50Kg and the subjects body mass index (BMI) must be within 18.5 - 25.0 (Kg/m2) (inclusive).
- •3.Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21days prior to commencement of the study.
- •4.Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance.
- •5.Informed consent form given in written form.
- •6.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
排除标准
- •1.History or presence of significant:
- •1.1.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Gabapentin and/or any related compounds etc.
- •1.2.Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •1.3.Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •1.4.Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products (more than or equal to 4 chews/day).
- •1.5.History of difficulty in swallowing or coming for follow up.
- •1.6.Clinically significant illness within 4 weeks before the start of the study
- •1.7.Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study
- •1.8.Female subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening and prior to each period.
- •1.9.Positive result to HIV, HCV and HBsAg.
- •1.10.Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Valproic acid, etc.) in the previous 30 days before day 1 of this study.
- •1.11.Abnormal 12 lead ECG, X-ray.
- •2.Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
- •3.Participation in another clinical trial within the preceding 90 days of study starts.
- •4.Subjects who have:
- •4.1.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- •4.2.Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the principal investigator.
- •4.3.Pulse rate below 60/min. or above 100/min
研究者
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