malaria
Conditions
Interventions
A group:AL-AQ-ALAQ
B group:AQ-AL-ALAQ
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions ADRs; 2.Able to complete the trial in compliance with the protocol; 3.Participants including males willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 6 months after the last administration; 4.Males and females between 18 and 55 years old at the time of signing the informed consent form, inclusive; 5.Before admission, At least 55 kg, with a Body Mass Index BMI between 18.5-30.0 kg/m^2, inclusive; 6.No history of chronic or serious cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.
Exclusion criteria
Exclusion criteria: 1.With = 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 2.Allergic to two or more substances, or specific allergy history e.g. asthma, allergic rhinitis, urticaria, eczema, or allergic to the drug components and its analogues; 3.A history of alcohol abuse within one year prior to screening alcohol consumption of more than 14 units per week: 1 unit of alcohol: 285 mL beer, or 25 mL spirits, or 100 mL wine; 4.Blood donation or massive blood loss = 200 mL, or donation of component blood, or blood transfusion within 3 months before the initial administration, or any blood donation plan from screening until 3 month after the last administration; 5.A history of dysphagia, or any gastrointestinal disease which may affect the drug absorption; 6.A family history of congenital QT prolongation or sudden death; or a history of congenital QT prolongation e.g., long QT syndrome or any clinical condition known to prolong the QTc interval, such as a history of symptomatic cardiac arrhythmias, clinically significant bradycardia, or other severe cardiac disease; 7.Patients with a history of liver injury or clinically significant hematologic events following treatment with amodiaquine; 8.Retinopathy; 9.Participants who have received a vaccination within 30 days prior to taking the investigational drug, or who plan to receive a vaccination during the trial or within 3 months after the final dose; 10.Use of any medication that affects liver enzyme activity or prolongs the QT interval within 30 days prior to taking the investigational drug e.g., Class Ia quinidine, procainamide, disopyramide or Class III amiodarone, sotalol antiarrhythmic drugs; neuroleptics, antipsychotics pimozide, ziprasidone; antidepressants; certain antibiotics macrolide antibiotics, fluoroquinolone antibiotics, imidazole and triazole antifungals; certain non-sedating antihistamines terfenadine, astemizole and cisapride or drugs metabolized by CYP2D6; or any antimalarial drugs; 11.Any prescription medication, over-the-counter OTC medication, herbal medicine or health supplementary within 14 days before the initial administration; or still within 5 times the half-life of any medication prior to taking the investigational drug if the half-life is known; 12.Participants with irregular diet or obviously abnormal dietary habits such as dieting within 4 weeks prior to screening. 13.Consumption of any special diets or food items such as grapefruit, pomelo, papaya, carambola and pomegranate, or strenuous exercise engagement, or other factors in the opinion of investigators affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration, or those who have a weight loss plan during the trial; 14.Participation in other drug clinical trials and received investigational drugs or device clinical trials within 3 months before the initial administration; 15.Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram, laboratory tests, abdominal B-ultrasound, chest X-ray, and ophthalmoscopy, ect; 16.Those with blood potassium or magnesium levels out of the normal range during screening; 17.The QTc interval of the ECG results during screening for males >450 ms or females >460 ms; 18.Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis; 19.Consum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| artemether and its metabolite dihydroartemisinin;lumefantrine;amodiaquine and its metabolite desethylamodiaquine; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;vital signs;laboratory test;ECG-related indicators; | — |
Countries
China
Contacts
Public ContactHongjie Qian
Shanghai Xuhui Central Hospital
Outcome results
None listed