HealthyPhase 1NCT01146028

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

A Phase 1 study testing Tizanidine in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tizanidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteCanada
Study dates: Sep 2001to Nov 2001
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site). Subjects must meet all of the following criteria in order to be included in the study:
Subjects will be females and/or males, smokers or non-smokers, 18 years of age and older.
Female subjects will be post-menopausal or surgically sterilized.
Post-menopausal status is defined as absence of menses for the past 12 months.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Who cannot join

Subjects to whom any of the following applies will be excluded from the study:
Clinically significant abnormalities found during medical screening.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Clinically significant illnesses within 4 weeks of the administration of study medication.
History of neuromuscular disease.
Abnormal laboratory tests judged clinically significant.

Show all 20Show fewer

ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, or diastolic blood pressure lower than 70 or over 90; or heart rate less than 60 bpm) at screening.
Subjects with BMI ≥ 30.0.
History of allergic reactions to tizanidine hydrochloride.
Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub investigator, contraindicates the subject's participation in this study.
Positive urine drug screen at screening.
Positive testing for hepatitis B, hepatitis C or HN at screening.
Positive urine pregnancy test at screening.
Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (l Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot)within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
Subjects who have taken prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Smoking more than 25 cigarettes per day.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
Any reason which, in the opinion of the medical sub investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm Inc.
Sainte-Foy (Quebec)

Other trials in Canada

About this study

Official title: 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

Read the detailed 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

Conditions: Healthy
Being tested: Tizanidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TizanidineDrug
Also called Zanaflex 4 mg
Tizanidine HCl Tablets 4 mg

Study groups in NCT01146028
Study group	Role	What they receive
Tizanidine HCl 4 mg	Experimental	Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited Receives: Drug: Tizanidine
Zanaflex	Active comparator	Zanaflex 4 mg Tablets Receives: Drug: Tizanidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence based on Cmax and AUC parameters
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2001Nov 2001

First posted17 Jun 2010 (estimated)
Study startSep 2001
Primary completionSep 2001
Study completionNov 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01146028
Sponsor's protocol ID: 01220
Status last verified: Jun 2010
First submitted: 10 Feb 2010
Last updated: 13 Jan 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01146028
Acronym / sponsor ID: 01220
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
Study start: Sep 2001
Primary completion: Sep 2001 (actual)
Study completion: Nov 2001 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tizanidine HCl 4 mg	Experimental	Drug: TizanidineTizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
Zanaflex	Active comparator	Drug: TizanidineZanaflex 4 mg Tablets

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site). Subjects must meet all of the following criteria in order to be included in the study:
Post-menopausal status is defined as absence of menses for the past 12 months.
Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Key exclusion criteria (20 listed)

Clinically significant abnormalities found during medical screening.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Clinically significant illnesses within 4 weeks of the administration of study medication.
History of neuromuscular disease.
Abnormal laboratory tests judged clinically significant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TizanidineAlso: Zanaflex 4 mgTizanidine HCl Tablets 4 mg	Drug	Tizanidine HCl 4 mg, Zanaflex

Primary outcome

Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benoit Girard, M.D principal investigator

Anapharm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tizanidine in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequivalence based on Cmax and AUC parameters (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146028.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.