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Sofusa System With Sumatriptan (KC5010) Phase 1 Pharmacokinetics and Safety Study (KCC-SMT-002)

2017-07-27 12:23:21 | BioPortfolio

Summary

Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.

Study Design

Conditions

Migraine Disorders

Intervention

Sumatriptan Succinate Oral Tablet, Transdermal delivery of sumatriptan succinate

Status

Not yet recruiting

Source

Kimberly-Clark Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-07-27T12:23:21-0400

Clinical Trials [1998 Associated Clinical Trials listed on BioPortfolio]

Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg

The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100...

Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 10...

Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg

The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100...

Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®

The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to as...

Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions

An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions

PubMed Articles [8056 Associated PubMed Articles listed on BioPortfolio]

Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers.

Previous studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation. Therefore, we have conducted the present study, where sumatriptan is ...

Sumatriptan effects on morphine-induced antinociceptive tolerance and physical dependence: The role of nitric oxide.

Sumatriptan, a 5HT (5-hydroxytryptamine) receptor agonist, showed neuroprotection in different studies. The aim of the present study was to investigate the effect of sumatriptan on morphine-induced a...

Modelling the in-vitro dissolution and release of sumatriptan succinate from polyvinylpyrrolidone-based microneedles.

A mathematical model was developed to predict the transport of sumatriptan molecules across the skin followed by absorption into the bloodstream. The drug was encapsulated in dissolving polyvinylpyrro...

Metabolic engineering of for efficient production of succinate from lignocellulosic hydrolysate.

Succinate has been recognized as one of the most important bio-based building block chemicals due to its numerous potential applications. However, efficient methods for the production of succinate fro...

Curcumin inhibits hepatic stellate cell activation via suppression of succinate-associated HIF-1α induction.

Aberrant succinate accumulation emerges as a unifying mechanism for inflammation and oxidative stress. This study aims to investigate whether curcumin ameliorates hepatic fibrosis via blocking succina...

Medical and Biotech [MESH] Definitions

Enzymes that catalyze the first step leading to the oxidation of succinic acid by the reversible formation of succinyl-CoA from succinate and CoA with the concomitant cleavage of ATP to ADP (EC 6.2.1.5) or GTP to GDP (EC 6.2.1.4) and orthophosphate. Itaconate can act instead of succinate and ITP instead of GTP.EC 6.2.1.-.

An enzyme that plays a role in the GLUTAMATE and butanoate metabolism pathways by catalyzing the oxidation of succinate semialdehyde to SUCCINATE using NAD+ as a coenzyme. Deficiency of this enzyme, causes 4-hydroxybutyricaciduria, a rare inborn error in the metabolism of the neurotransmitter 4-aminobutyric acid (GABA).

A flavoprotein containing oxidoreductase that catalyzes the dehdyrogenation of SUCCINATE to fumerate. In most eukaryotic organisms this enzyme is a component of mitochondrial electron transport complex II.

An enzyme that catalyzes the oxidation of succinate semialdehyde to SUCCINIC ACID. It plays a role in the metabolism of GLUTAMATE; TYROSINE; and butanoate.

An electron transport chain complex that catalyzes the transfer of electrons from SUCCINATE to CYTOCHROME C. It includes ELECTRON TRANSPORT COMPLEX II and ELECTRON TRANSPORT COMPLEX III.

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