PACTR202111661886287尚未招募1 期
Single dose oral bioequivalence study of Primaquine 15 mg tablet (test product) and Primaquine 15 mg tablet (reference product) in healthy adult human subjects under fasting conditions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1)Age:18 to 55 years old, inclusive.
- •2)Gender:Male and/or non-pregnant, non-lactating female.
- •3)BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- •4)Able to communicate effectively with study personnel.
- •5)Willing to provide written informed consent to participate in the study.
- •6)Non-smokers and nontobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- •7)All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication
排除标准
- •1)History of allergic responses to Primaquine or other related drugs, or any of its formulation ingredients.
- •2)Have known significant diseases or clinically significant abnormal findings during screening (medical history, physical examination, laboratory evaluations, ECG).
- •3)Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- •4)History or presence of bronchial asthma.
- •5)Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- •6)A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •7)Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see http://medicine.iupui.edu/clinpharm/ddis/main-table).
- •8)History or evidence of drug dependence or of alcoholism or of moderate alcohol use (> 14 units/week: 1 unit = 1 shot of spirits, ½ pint of beer, 1.5 = 125 mL of wine Alcohol units - NHS (www.nhs.uk).
- •9)History of difficulty with donating blood or difficulty in accessibility of veins.
- •10)A positive hepatitis screen (includes subtypes B & C).
- •11)A positive test result for HIV antibody and / or syphilis (RPR).
- •12)Volunteers who have received a known investigational drug within seven elimination half-lives of the administered drug prior to first dose of study medication or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the first dose of study medication, whichever is greater.
- •13) Volunteers who have donated blood or loss of blood > 300 mL within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- •14)History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- •15)Intolerance to venepuncture
研究者
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