CTRI/2015/05/005738已完成未知
An open-label, single-dose, single-period, safety, tolerability and pharmacokinetic study of 500 mg/2 mL paracetamol intramuscular injection of Troikaa Pharmaceuticals Ltd., India in healthy, human, adult, male subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •i. Healthy, Indian, male, fair human volunteers aged from 18 to 45 years.
- •ii. Body mass index should be within 18.0-24.75 kg/m2.
- •iii. Hip circumference should be within 85 - 110 cms.
- •iv. Voluntarily willing and capable to give written and signed informed consent prior to participation in the study, according to the form attached in appendix - 1.
- •v. Availability for the entire study period and willingness to adhere to the protocol and study requirements.
- •vi. Voluntarily willing to undergo pre- and post-study physical examinations and laboratory investigations.
- •vii. Having no significant disease or abnormal laboratory values on laboratory examination with no clinical relevance, medical history or physical examination during screening.
- •viii. 12-lead supine EeG in resting position and vital signs within normal limits or showing minor aberrations, which the investigator does not consider of clinical relevance.
- •ix. Normal chest X-ray findings or findings that have no clinical correlation.
- •x. Non-smokers
- •xi. Having not consumed alcohol at least 48 hrs. prior to the IMP administration justified by negative breath-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
- •xii. Negative unne test for drug of abuse [amphetamine, barbiturate,tetrahydrocannabinoids, morphine, cocaine, benzodiazepine].
- •xiii. Having not consumed grapefruit or orange juice/products within 48 hrs. of the IMP administration.
排除标准
- •i. History of allergy or sensitivity to paracetamol or any other drug, which, in the opinion of the investigator, would compromise the safety of the subject or the study.
- •ii. History of epilepsy, previous history of severe respiratory disorders such as chronic obstructive airways disease, tuberculosis, pleurisy or pneumonia within last 1 year.
- •iii. History of diseases of liver or hepatic impairment within last one [1] year.
- •iv. Elevated serum transaminases [SGOTI SGPT] or alkaline phosphatase.
- •v. Serious, uncontrolled disease [including serious psychological disorders] likely to interfere with the study andlor likely to cause death within the study duration.
- •vi. Participation in another clinical study or a blood donation program or having had blood loss of more than 350 mL during the last 90 days.
- •vii. Renal insufficiency [serum creatinine more than twofold of >3 mg/dL].
- •viii. Seropositive for VDRL, HIV [lor II] or hepatitis B or C infection.
- •ix. Any clinically significant abnormality [to be determined by the investigator] following review of screening laboratory data and full physical examination.
- •x. Vital sign abnormalities [systolic blood pressure < 100 or > 140 mmHg or diastolic blood pressure < 60 or > 90 mmHg or heart rate < 50 bpm or > 120 bpm] at the preadmission physical examination.
- •xi. Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study.
- •xii. Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug.
- •xiii. Having taken OTC or prescribed medications, including any enzyme-modifying drugs or any systemic medication, within the last 30 days prior to the study.
- •xiv. Having a history of alcohol or substance abuse within the last 5 years.
- •xv. Habit of chewing or inhaling nicotine-containing products [e.g. tobacco] currently or within last six months prior to the study.
- •xvi. Abnormal INR combined with clinical manifestation.
- •xvii. Consumption of xanthine-containing derivatives [coffee, tea, cola drinks, chocolate] within 24 hrs. before IMP administration and grapefruit or orange juice for at least 48 hrs. prior to IMP administration.
研究者
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