CTRI/2015/01/005468进行中（未招募）未知
A randomized, open label, two treatment, two period, two sequence, multiple dose, crossover, steady state pharmacokinetics and bioavailability study of Xykaa Extend 1000 of Troikaa Pharmaceuticals Ltd., India and Calpol 500 mg tablet of Glaxosmithkline, India in healthy human adult subjects, under fasting condition.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 18
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 human adult literate subjects between 18-45 years of age (inclusive), having a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive).
- •ii. Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to study start.
- •iii. Subjects whose screening laboratory values, vital signs, ECG and chest X- ray are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- •iv. Nonsmokers or ex-smokers (nonsmokers for at least 3 months).
- •v. Subjects do not consume any other form of tobacco products.
- •vi. Informed consent given in written form according to section 11.3 of the protocol.
- •vii. Female Subjects
- •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- •postmenopausal for at least 1 year.
- •surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
排除标准
- •1. Known history of
- •i. Cardiovascular, pulmonary, hepatic or liver impairment, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •ii. Elevated serum transaminases [SGOT/ SGPT] or alkaline phosphatase
- •iii. Asthma, urticaria or other allergic type reactions after taking any medication.
- •iv. Hypersensitivity to Paracetamol and any other similar class of drugs or any of its excipients.
- •2. History or presence of
- •i. Significant alcohol dependence, alcohol abuse or drug abuse within past one year.
- •ii. Moderate to heavy smoking (more than 10 cigarettes/day)
- •iii. Consumption of tobacco products more than 4 packets/day.
- •iv. Difficulty in swallowing tablet/capsule.
- •v. Clinical illness within 4 weeks before the start of the study
- •i. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the preceding 90 days prior to the start of the study.
- •ii. Subject has donated blood in the preceding 90 days prior to the start of the study.
- •4. Subject who have Positive Urine drug screening, Alcohol breath analysis, HIV,
- •VDRL/RPR, Hepatitis B & C tests.
- •5. Subjects who have:
- •i. Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg
- •ii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.
- •iii. Pulse rate below 60 beats/minute or above 100 beats/minute.
- •6. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
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