A randomized, cross over study on pharmacokinetics of single oral dose of 15mg and 45 mg Primaquine in healthy human volunteers - NI

I0 个研究点目标入组 12 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Participants judged healthy by medical history and physical examination
•2. Normal hematological and biochemical parameters and urine parameters
•3. Participants have not taken any drug 15 days prior to and during the study
•4. No previous history of gastrointestinal, hepatic, renal, cardiovascular or psychiatric diseases or symptoms.
•5. Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 25.0 kg/m2, extremes included
•6. Negative HBsAg and HIV ELISA
•7. Female of non-child bearing potential or of child bearing potential with negative urine pregnancy test
•8. Willing to provide written informed consent
•9. Willing to comply with protocol instructions and duration of follow up.

•1.G6PD deficiency
•2.Peripheral smear positive for any malarial species
•3.History of malaria in the past one month.
•4.Known hypersensitivity to primaquine or related drugs (e.g., iodoquinol)
•5.Persons receiving treatment with other drugs producing hemolysis.(appendix 2)
•6.Pregnant (even if a pregnant woman is G6PD normal, the fetus may not be) or breast feeding women
•7.Participation in any investigational new drug study within 4 weeks prior to dosing.
•8.Donation or loss of 300 ml or more of blood within 8 weeks prior to study start
•9.History of autoimmunae disease or clinically significant drug allergy
•10.History of drug or alcohol abuse within the last 6 months

发起方

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