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HealthyPhase 1NCT01066767

Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions

A Phase 1 study testing Fexofenadine 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.

Official record
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Trial summary

Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under Fed 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?
Fexofenadine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
Apr 2002to May 2002
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 Inc.
  • Web site, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:
  • Subjects will be females and/or males, smokers and 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 or hysterectomy with bilateral oophorectomy at least 6 months ago.
  • 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 illnesses within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the medical sub investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
Show all 26Show fewer
  • Positive urine drug screen at screening.
  • Positive testing for hepatitis B, hepatitis C or HN at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm or over 100 bpm) at screening.
  • Subjects with BMl ≥ 30.0.
  • 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 (1 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) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical Sub investigator, contraindicates the subject's participation in this study.
  • History of allergic reactions to fexofenadine hydrochloride or its ingredients.
  • History of allergic reactions to heparin.
  • 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.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement)within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Subjects who have a depot injection or an implant of any drug 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
  • less than 300 mL of whole blood within 30 days or
  • 300 mL to 500 mL of whole blood within 45 days or
  • more than 500 mL of whole blood within 56 days.
  • Smoking more than 25 cigarettes per day.
  • Additional exclusion criteria for females only:
  • Breast-feeding subjects.
  • Positive urine pregnancy test at screening (performed on all females).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Anapharm Inc.,

    Sainte-Foy Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets and Allegra® 180 mg Tablets Administered as 1 x 180 mg Tablet in Healthy Subjects Under Fed Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered as

1 x 180 mg Tablet in Healthy Subjects under Fed Conditions

Read the detailed description

The objective of this study is to compare the rate and extent of absorption of fexofenadine hydrochloride 180 mg tablets (test) versus Allegra® (reference) administered as 1 x 180 mg tablet under fasting conditions. Single oral dose (1 x 180 mg) in each period with a washout of at least 7 days between doses.

Conditions
Healthy
Being tested
Fexofenadine

What participants receive

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

  • FexofenadineDrug

    Also called Allegra 180 mg Tablets

    Fexofenadine Hydrochloride 180 mg Tablets

Study groups in NCT01066767
Study groupRoleWhat they receive
FexofenadineExperimentalFexofenadine Hydrochloride 180 mg Tablets Dr. Reddy's Laboratories Limited
Receives: Drug: Fexofenadine
AllegraActive comparatorAllegra Tablets 180 mg Aventis Pharmaceuticals Inc.,
Receives: Drug: Fexofenadine

What is being measured

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

  1. Bioequivalence study of Dr. Reddys, Fexofenadine Hydrochloride 180 mg tablets

    Measured: 2 months

Timeline

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

  1. First posted10 Feb 2010 (estimated)
  2. Study startApr 2002
  3. Primary completionMay 2002
  4. Study completionMay 2002

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01066767
Sponsor's protocol ID
02041
Status last verified
Feb 2010
First submitted
9 Feb 2010
Last updated
10 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fexofenadine 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 6 inclusion and 26 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 10 Feb 2010. 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 study of Dr. Reddys, Fexofenadine Hydrochloride 180 mg tablets (time frame: 2 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 NCT01066767.

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 10 Feb 2010.

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