Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions

2014-08-26 22:12:49 | BioPortfolio

Summary

The purpose of this bioequivalence study is to compare the test Tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fasting conditions.

Description

Randomized, 2-way crossover, bioequivalence study of Tizanidine Hydrochloride 4mg tablets and zanaflex® 4mg tablets administered As 1 x 4mg tablet in healthy adult subjects under fasting conditions

Study Design

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

Conditions

Healthy

Intervention

Tizanidine

Location

Anapharm Inc.
Sainte-Foy (Quebec)
Canada

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:12:49-0400

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This open-label, multicenter, 3-period, fixed-sequence study will evaluate the e ffect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in ...

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PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Tizanidine Withdrawal Symptoms in Stress Cardiomyopathy.

Introduction: An acute discontinuation of tizanidine, an alpha-2-agonistic muscle relaxant, is associated with reflex tachycardia, hypertension, tremor, hypertonicity and anxiety. Case Report: We desc...

Rapid simultaneous determination of eperisone, tolperisone, and tizanidine in human serum by using a MonoSpin® C18 extraction column and liquid chromatography/tandem mass spectrometry.

A method was developed for rapid toxicological analysis of eperisone, tolperisone, and tizanidine in human serum using a MonoSpin® C18 extraction column and LC/MS/MS. The method was validated for LOD...

A Case of Stiff Person Syndrome: Immunomodulatory Effect of Benzodiazepines: Successful Rituximab and Tizanidine Therapy.

Stiff person syndrome (SPS) is a rare autoimmune disease. Most patients have high-titer antibodies against glutamate decarboxylase (GADAb), which is without practical value in disease monitoring. Benz...

Interventions to Reduce Spasticity and Improve Function in People With Chronic Incomplete Spinal Cord Injury: Distinctions Revealed by Different Analytical Methods.

Background. Spinal cord injury (SCI) results in impaired function, and ankle joint spasticity is a common secondary complication. Different interventions have been trialed with variable results. Objec...

Variability in responsiveness to interventions in people with spinal cord injury: Do some respond better than others?

Spinal cord injury (SCI) results in significant impairments in function and ankle joint spasticity is a common secondary complication. Various interventions have been trialed to improve function and r...

Medical and Biotech [MESH] Definitions

None available.

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