Bioequivalence study of a New Formulation of Artesunate

Not Applicable

Completed

• Conditions: Healthy volunteer study; Chemicals and Drugs [D]

• Registration Number: TCTR20170907002
• Lead Sponsor: Guilin Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-07
• Study Completion: 2018-07-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1)Healthy male and female subjects aged 18-55 years
2)Body mass index of 18-25 kg/m2
3) No evidence of underlying disease, physically or mentally disabled or clinically significant abnormal finding during screening and/or medical history examination
4)A female is eligible to participate in this study if she is
• of non-childbearing potential including pre-menopausal females
with documented (medical report verification) hysterectomy or
double oophorectomy, or
• of non-childbearing potential including post-menopausal females
defined as 12 months of spontaneous amenorrhea or 6 months of
spontaneous amenorrhea with serum follicle stimulating hormone
levels >40 mIU/mL or 6 weeks post-surgical bilateral oophorectomy
with or without hysterectomy, or
• of childbearing potential, but has a negative serum pregnancy test
at screening and prior to study drug administration in each
period, and willingness to abstain from sexual intercourse or
agrees to using effective contraceptive methods (e.g.,
intrauterine device, hormonal contraceptive drug, tubal ligation
or female barrier method with spermicide) during the study period
until completion of the follow-up procedures
5)A male is eligible to enter and participate in this study if he agrees to abstain from sexual intercourse with females of childbearing potential or is willing to use a condom/spermicide during the study until completion of the follow-up procedures
6)Normal ECG with Fridericia-corrected QT (QTcF) and Bazett-corrected QT (QTcB) intervals < 450 msec
7)Willing to participate in this study and sign the Informed Consent Form

Exclusion Criteria

1)Any history of hypersensitivity to artesunate or known hypersensitivity to any component of the formulations
2)History of abnormal bleeding after minor injury or prolong hematoma following the intramuscular injection
3)Family history of any bleeding tendency
4)Platelet < 150,000 /µl
5)PT or PTT > upper normal limit or INR > 1.5
6)AST or ALT > 1.5 ULN
7)Creatinine clearance (CLcr) <70 mL/min as determined by Cockcroft-Gault equation
8)Personal and/or family history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, risk factors for torsades de points (heart failure, hypokalaemia), or with a family history of sudden cardiac death
9)Administration of a known drug that can cause damage to organs or other medicinal products known to prolong the QT interval (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine, and piperaquine) in the preceding 3 months prior to the start of the study
10)Participation in a clinical trial or receiving a prescription drug, non-prescription drug or a new chemical entity within 30 days, 5 half-lives or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication
11)Donation of blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Plasma or blood donation during the study is not acceptable
12)HIV, HBV, or HCV positive
13)Malaria positive
14)History of alcohol or substance abuse or dependence
15)Unwillingness to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen
16)Receiving any form of anticoagulant within 14 days prior to start study drug, plan to receive any form of anticoagulant while participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Artesunate and DHA concentration in plasma Frequent sampling for 24 hours post dose AUC0-∞ and AUC0-LAST, CMAX, CL, T1/2, TMAX, Vd

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability Frequent measurements for 24 hours post dose Vital signs, and ECG measurements ,Laboratory evaluations Before drug administration and before discharge in each study occasion Biochemistry and Haematology ,Adverse effects includes dizziness, light-headedness, rash and tasted alteration After drug administration throughout the study period Physical examination