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

23:33 EDT 22nd August 2014 | 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 [2 Associated Clinical Trials listed on BioPortfolio]

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 [4 Associated PubMed Articles listed on BioPortfolio]

Patient Education and Self-Care for the Management of Jaw Pain upon Awakening: A Randomized Controlled Clinical Trial Comparing the Effectiveness of Adding Pharmacologic Treatment with Cyclobenzaprine or Tizanidine.

Aims: To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenti...

Suppression of the cough reflex by α 2-adrenergic receptor agonists in the rabbit.

The α 2-adrenergic receptor agonist clonidine has been shown to inhibit citric acid-induced cough responses in guinea pigs when administered by aerosol, but not orally. In contrast, oral or inhaled c...

Evaluation of Oral Tiazinidine Effects on intraoperative Hemodynamic Responses During Direct Laryngoscopy Under General Anesthesia.

Direct laryngoscopy and tracheal intubation can result in blood pressure and heart rate increase which in turn may lead to myocardial ischemia, cerebral hemorrhage, and even death in susceptible patie...

Pathophysiology, assessment and management of multiple sclerosis spasticity: an update.

Spasticity is one of the most common and disabling symptoms associated with multiple sclerosis (MS). MS spasticity occurs through both myelin and nerve fiber (axonal) degradation, which commence in th...

Medical and Biotech [MESH] Definitions

None available.

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