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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 [499 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.

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.

Safety and Efficacy Study of IV Artesunate to Treat Malaria

The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malar...

PubMed Articles [469 Associated PubMed Articles listed on BioPortfolio]

Blackwater fever in a non-immune patient with Plasmodium falciparum malaria after intravenous artesunate.

Blackwater fever was typically reported after quinine administration, although it is poor recognized in patients receiving artesunate. This case describes a blackwater fever in a non-immune patient af...

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...

Prophylaxis and Therapy of Malaria: Current Recommendations.

Malaria incidence is decreasing on a global scale, while the number of imported cases has remained at a high level in Germany. To decrease this number, counselling of travellers to malaria-endemic reg...

Plasmodium-Salmonella Co-Infection Induces Intense Inflammatory Responsanirban Pal, Phd, Cisr-Central Institute of Medicinal and Aromatic Plants, Lucknow, Uttar Pradesh Indiae, Oxidative Stress and Liver Damage: A Mice Model Study for Therapeutic Strategy.

Impairment of host immune response in malaria favours bacteraemia caused by typhoidal or non-typhoidal serovars of Salmonella enterica. Ofloxacin and Artesunate are the drugs that are clinically prove...

Impact of treatment and re-treatment with artemether-lumefantrine and artesunate-amodiaquine on selection of Plasmodium falciparum multidrug resistance gene-1 polymorphisms in the Democratic Republic of Congo and Uganda.

The emergence of resistance against artemisinin combination treatment is a major concern for malaria control. ACTs are recommended as the rescue treatment, however, there is limited evidence as to whe...

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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