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Skeletal Muscle Relaxant

Tizanidine HCl 4 mg for Healthy Subjects

Phase 1
Waitlist Available
Led By Benoit Girard, M.D
Research Sponsored by Dr. Reddy's Laboratories Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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 fed conditions.

Eligible Conditions
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 4 trial • 320 Patients • NCT03068897
4%
Gastrointestinal complaint
3%
Drowsiness
1%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metaxalone
Tizanidine
Baclofen
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tizanidine HCl 4 mgExperimental Treatment1 Intervention
Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
Group II: ZanaflexActive Control1 Intervention
Zanaflex 4 mg Tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tizanidine
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dr. Reddy's Laboratories LimitedLead Sponsor
235 Previous Clinical Trials
47,463 Total Patients Enrolled
Benoit Girard, M.DPrincipal InvestigatorAnapharm
4 Previous Clinical Trials
120 Total Patients Enrolled
~1 spots leftby Nov 2025
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