Healthy Clinical Trial
Official title:
Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered Primaquine and Pyronaridine-Artesunate in Healthy Adult Subjects
The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification
of early detection as well as treatment monitoring in malaria infection. It is widely
accepted that the development of resistance can be delayed by the use of combination
therapy, especially combinations that include artemisinin derivatives (acts). As the
resistance problem is considered extremely serious; as a consequence, who has recommended
that all monotherapy for malaria should be stopped.
Current WHO guidelines recommend that the drug combination regimens using ACT with effective
partner medicines should be used to decrease the risk of development or spreading of
artemisinin resistance.
Current WHO guidelines recommend that the drug combination regimens using ACT with effective
partner medicines should be used to decrease the risk of development or spreading of
artemisinin resistance.
Pyronaridine (PP) and artesunate (AS) are antimalarial agents with a history of clinical use
both separately and in combination with other drugs. Each drug has powerful
anti-schizonticidal actions. The action of artesunate is a rapid knock-down of the
parasites, after which the drug is rapidly cleared as it has a short systemic half-life.
Pyronaridine is also effective in the short-term but has an intermediate blood half-life
thus providing a sustained schizonticidal effect. The aim of the fixed dose combination of
pyronaridine and artesunate (PA or PYRAMAX®) in the treatment of uncomplicated acute malaria
is to provide a rapid reduction in parasitemia with a short-term regimen, thereby improving
compliance and reducing the risk of recrudescence through the slower elimination of
pyronaridine. Doses have been selected to be in line with current prescribing practice for
these agents when used as mono-therapy.
Primaquine (PQ) is an effective gametocytocide for P. falciparum transmission prevention and
as tissue killing for the radical cure in P. vivax and P. ovale infection. It will be given
only in the presence of other antimalarials, so it is necessary to study the drug
interactions between primaquine, pyronaridine and artesunate. It is inevitable that in the
near future, pyronaridine-artesunate (PA) and primaquine (PQ) combination treatment will
become necessary. These drugs are metabolized by cytochrome P450 enzymes which potentially
causes pharmacokinetic alteration and clinically significant drug-drug interactions that can
lead to unanticipated adverse reactions or therapeutic failures because of the suboptimal
exposure of the parasite.
This study is planned to evaluate potential pharmacokinetic interaction of orally
administered primaquine and pyronaridine-artesunate (PYRAMAX®) in healthy adult subjects.
The results of these interaction studies are important in order to provide clinical guidance
for the optimum combination primaquine and pyronaridine-artesunate (PYRAMAX®) treatment
regimens in malaria infections.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |