Advertisement

Topics

A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults

2014-07-23 21:13:26 | BioPortfolio

Summary

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Study Design

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

Conditions

Chemotherapy-Induced Nausea and Vomiting

Intervention

Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron), Comparator: Treatment C (Zofran, ondansetron)

Status

Completed

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:26-0400

Clinical Trials [1538 Associated Clinical Trials listed on BioPortfolio]

Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose admin...

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg

Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a singl...

Fasting Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a singl...

Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fa...

PubMed Articles [28520 Associated PubMed Articles listed on BioPortfolio]

Identification of novel ondansetron metabolites using LC/MS and NMR.

Ondansetron, a potent and highly sensitive 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, has been used for the treatment of chemotherapy- and radiotherapy-induced nausea and vomiting. The is...

Ondansetron - a promising adjunctive treatment for persistent schizophrenia.

Ondansetron is a serotonin 3 receptor antagonist widely used to prevent nausea and vomiting in pregnancy and in patients receiving chemotherapy. There is growing evidence that adjunctive ondansetron t...

Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects.

To use data from two large studies of birth defects to describe time trends in ondansetron use for the treatment of first-trimester nausea and vomiting of pregnancy and to investigate associations, ei...

Pharmacokinetics of R-(-)ondansetron compared with that of S-(-)ondansetron in rats using a LC-MS/MS method.

To study pharmacokinetics of R-(-)ondansetron (R-ond) compared with that of S-(-)ondansetron (S-ond) in rats.

Ondansetron and teratogenicity in rats: evidence for a mechanism mediated via embryonic hERG blockade.

The potent hERG channel blocking drug ondansetron is used off-label for treatment of nausea and vomiting in early pregnancy. Some human epidemiological studies have associated ondansetron with fetal c...

Medical and Biotech [MESH] Definitions

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Procedures, surgery, or other treatment without consent of person or persons receiving treatment.

Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.

A vasodilator that also has bronchodilatory action. It has been employed in the treatment of angina pectoris, in the treatment of asthma, and in conjunction with ultraviolet light A, has been tried in the treatment of vitiligo. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1024)

A treatment method in which patients are under direct observation when they take their medication or receive their treatment. This method is designed to reduce the risk of treatment interruption and to ensure patient compliance.

More From BioPortfolio on "A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial