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Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

2014-08-27 03:30:26 | BioPortfolio

Summary

The objective of the study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malaria

Intervention

pyronaridine artesunate

Location

Cross Research S.A., Phase I Unit
Arzo
Switzerland
6864

Status

Completed

Source

Medicines for Malaria Venture

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:26-0400

Clinical Trials [518 Associated Clinical Trials listed on BioPortfolio]

Pyronaridine Artesunate (3:1) Versus Mefloquine Artesunate in P Falciparum Malaria Patients

The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of the combination of mefloqui...

Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

The purpose of this study is to evaluate three dose levels of a combination of pyronaridine and artesunate for the treatment of uncomplicated falciparum malaria in children.

Drug Combinations of Atovaquone-Proguanil (AP) With ACT

Investigators are conducting this study due to recent reports of many of existing malaria drugs becoming less effective for treatment of malaria. The drugs may not always kill all the para...

ACT MALI: Treatment of Malaria Based on Combination Therapies

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of un...

Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria

The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.

PubMed Articles [420 Associated PubMed Articles listed on BioPortfolio]

The Antimalarial Drug Artesunate Attenuates Cardiac Injury in A Rodent Model of Myocardial Infarction.

Ischemic heart disease remains the leading cause of morbidity and mortality in the Western world. Artesunate is the WHO-recommended drug of choice for complicated malaria (with organ failure). The adm...

Impact on the transmission of malaria with different treatment schemes in the peruvian coast and amazon region within the framework of a policy on antimalarial medications, 1994-2017.

At the end of the 90s in Peru, after determining the resistance to antimalarial drugs, a change in antimalarial treatment schemes was decided; this change included the combined therapy for P. falcipar...

Optimal Treatments for Severe Malaria and the Threat Posed by Artemisinin Resistance.

Standard treatment for severe malaria is with artesunate; patient survival in the 24 hours immediately posttreatment is the key objective. Clinical trials use clearance rates of circulating parasites ...

Failure of intravenous artesunate treatment for Plasmodium falciparum malaria in a splenectomized traveller: A diagnostic challenge.

Efficacy of artemisinin-based combination therapies and prevalence of molecular markers associated with artemisinin, piperaquine and sulfadoxine-pyrimethamine resistance in Sierra Leone.

Currently, the national malaria control programme (NMCP) of Sierra Leone recommends artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) as first- and second-line treatment for uncomplicated...

Medical and Biotech [MESH] Definitions

Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.

Vaccines made from antigens arising from any of the four strains of Plasmodium which cause malaria in humans, or from P. berghei which causes malaria in rodents.

A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.

Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

A protozoan parasite that occurs naturally in the macaque. It is similar to PLASMODIUM VIVAX and produces a type of malaria similar to vivax malaria (MALARIA, VIVAX). This species has been found to give rise to both natural and experimental human infections.

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