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Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

2019-04-19 12:44:21 | BioPortfolio

Published on BioPortfolio: 2019-04-19T12:44:21-0400

Clinical Trials [366 Associated Clinical Trials listed on BioPortfolio]

Propafenone in the Treatment of Atrial Fibrillation

This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the con...

Propafenone Versus Amiodarone in Septic Shock

Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom a...

Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation

The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled sing...

Diflucan Bioequivalence Study For Transferring The Manufacture

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossove...

Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers

The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions. These...

PubMed Articles [40 Associated PubMed Articles listed on BioPortfolio]

Opportunities and Challenges Related to the Implementation of Model-Based Bioequivalence Criteria.

The science of bioequivalence and biosimilarity has greatly evolved over the past three decades. Current methods for assessing bioequivalence mostly rely on noncompartmental pharmacokinetic analyses, ...

Bioequivalence of Sarpogrelate in Healthy Chinese Subjects Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Investigation by a Reference-Scaled Average Bioequivalence Approach.

Sarpogrelate is widely used to treat peripheral vascular disorders. However, it has been demonstrated to have a poor pharmacokinetic (PK) profile and marked within-subject variability. Here, the bioeq...

Assessment of individual bioequivalence using sufficient bootstrap procedure.

This paper proposes a sufficient bootstrap method, which uses only the unique observations in the resamples, to assess the individual bioequivalence under 2 × 4 randomized crossover design. The f...

Bioequivalence comparison of pediatric Dasatinib formulations and elucidation of absorption mechanisms through integrated PBPK modeling.

Sprycel® (Dasatinib) is a BCS II weakly basic drug that exhibits strong pH dependent solubility. Dasatinib is currently presented in two drug product formulations as an adult immediate release tablet...

An Open-Label, Randomized, Pivotal Bioequivalence Study of Oral Rolapitant.

Rolapitant, a selective and long-acting neurokinin-1 receptor antagonist, is approved in an oral formulation for prevention of delayed chemotherapy-induced nausea and vomiting in adults. This pivotal ...

Medical and Biotech [MESH] Definitions

An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity. The drug is generally well tolerated.

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