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

21:37 EDT 25th May 2015 | 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

Clinical Trials [3 Associated Clinical Trials listed on BioPortfolio]

A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

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 ...

Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)

Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and nex...

One Year Extension Study To Protocol C2/5/TZ:MS-05

Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg sublingual tizanidine administered once nightly in MS patients who successfully completed Phase ...

PubMed Articles [5 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...

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...

Classifying and predicting endurance outcomes of α2-adrenergic agonist intervention in spinal cord injury.

Spinal cord injury (SCI) is a traumatic condition that can lead to both functional and neuromuscular impairments. Spasticity in the muscles surrounding the ankle joint caused by hypertonia is often re...

Medical and Biotech [MESH] Definitions

None available.

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