Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)

2014-08-27 03:17:07 | BioPortfolio


The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.


The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment




EUR-1025, EUR-1025, EUR-1025, EUR-1025


Algorithme Pharma INc.




Eurand S.p.A.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:07-0400

Clinical Trials [283 Associated Clinical Trials listed on BioPortfolio]

Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

Nausea and vomiting are frequently occurring problems in the palliative phase of patients with cancer. Between 20-50% of them regularly suffer from nausea, retching or vomiting. Often the ...

Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation...

The Montefiore Metoclopramide Study

Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments (EDs). However, little research has focused o...

Emend for Multiple-day Emetogenic Chemotherapy

The purpose of the study is to assess the effect of Emend (aprepitant) on nausea and vomiting associated with chemotherapy. Chemotherapy commonly causes nausea and vomiting and this affec...

Treatment of Chemotherapy-induced Nausea and Vomiting

Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic antiemtic therapy with the same treatment...

PubMed Articles [193 Associated PubMed Articles listed on BioPortfolio]

The ebb and flow of neurosurgery in a re-emerging sub-Saharan center. Lessons from consecutive 1025 operated cases and progress models . A prospective observational cohort study.

Evolution of neurosurgery in our center is defined by 2 active phases separated by a decade long latent phase. Our study evaluates our experience in the renaissance phase using a; window of 1025 opera...

Location-dependent effects of trauma on oxidative stress in humans.

Though circulating antioxidant capacity in plasma is homeostatically regulated, it is not known whether acute stressors (i.e. trauma) affecting different anatomical locations could have quantitatively...

Improved Surface-Enhanced Raman Spectroscopy Sensitivity on Metallic Tungsten Oxide by the Synergistic Effect of Surface Plasmon Resonance Coupling and Charge Transfer.

Increasing the sensitivity of non-noble metal sur-face-enhanced Raman spectroscopy (SERS) is an urgent issue that needs to be solved at present. Herein, metallic W18O49 nanowires with strong localized...

A Conductive and Highly Deformable All-Pseudocapacitive Composite Paper as Supercapacitor Electrode with Improved Areal and Volumetric Capacitance.

Flexible energy storage electronics have gained increasing attention in recent years, but the simultaneous acquiring of high volumetric and high areal capacities as well as excellent flexibility in or...

Factors related with osteoporosis treatment in postmenopausal women.

Although fractures had high mortality and morbidity, many studies proved that fracture risk might be decreased by pharmacological therapy, although a low treatment adherence rate is observed. The aim ...

Medical and Biotech [MESH] Definitions

A drug combination that contains DIPHENHYDRAMINE and THEOPHYLLINE. It is used for treating vertigo, motion sickness, and nausea associated with pregnancy. It is not effective in the treatment of nausea associated with cancer chemotherapy.

Emesis and queasiness occurring after anesthesia.

A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness.

Nontoxic laxative vermicide effective for taenia infestation. It tends to produce colic and nausea. It is also used as a veterinary fungicide, anthelmintic, and antiprotozoan. (From Merck, 11th ed.)

A phenothiazine antipsychotic used principally in the treatment of NAUSEA; VOMITING; and VERTIGO. It is more likely than CHLORPROMAZINE to cause EXTRAPYRAMIDAL DISORDERS. (From Martindale, The Extra Pharmacopoeia, 30th ed, p612)

More From BioPortfolio on "Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)"

Quick Search


Searches Linking to this Trial