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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

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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 [27918 Associated PubMed Articles listed on BioPortfolio]

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...

A Comparator-Hypothesis Account of Biased Contingency Detection.

Our ability to detect statistical dependencies between different events in the environment is strongly biased by the number of coincidences between them. Even when there is no true covariation between...

Ondansetron does not prevent physical dependence in patients taking opioid medications chronically for pain control.

In this study, we investigated the co-administration of ondansetron with morphine, and whether it could prevent the development of physical dependence in patients taking opioids for the treatment of c...

Prevention of Shivering during Spinal Anesthesia: Comparison between Tramadol, Ketamine and Ondansetron.

Shivering is an unpleasant experience after spinal anesthesia. We conducted this study to evaluate the efficacy of ondansetron, ketamine and tramadol for prevention of shivering.

Association of anti-emetic efficacy of Ondansetron with 18792A>G polymorphism in a drug target gene 5-HT3B in Pakistani population.

To evaluate the association of anti-emetic efficacy of ondansetron with 18792A>G polymorphism in the target gene of 5-hydroxytryptamine type 3 subtype B.

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.

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.

An internationally recognized set of published rules used for evaluation of cancer treatment that define when tumors found in cancer patients improve, worsen, or remain stable during treatment. These criteria are based specifically on the response of the tumor(s) to treatment, and not on the overall health status of the patient resulting from treatment.

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