- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053689
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
January 19, 2010 updated by: Dr. Reddy's Laboratories Limited
Randomized, 2-way Crossover, Bioequivalence Study of Glimepiride 1 mg Tablets and Amaryl 1 mg Tablets in Healthy Subjects Under Fed Condition
The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed condition.
Study Overview
Detailed Description
The study was Single centre, randomized, single-dose, open-label,2-way crossover, bioequivalence study to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed condition.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Sainte-Foy, Quebec, Canada, GIV 2KB
- Anapharm Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-child-bearing potential female,smoker and or non-smoker,18 years of age and older.
- Capable of consent.
- Non-child-bearing potential female subject:
- Post-menopausal state:absence of menses for 12 months prior to drug. administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
Exclusion Criteria:
Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses & 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.
- Positive testing for hepatitis B and C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- BMI≥30.0.
- History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (l Unit=150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to glimepiride or other sulfonylureas (e.g. chlopropamide,gliclazide, tolbutamide and glyburide).
- 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, rifampinlrifabutin; examples of inhibitors: antidepressants, cimetidine. diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication. .
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea. inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism. or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological,endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication (including hormone therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Difficulty to swallow study medication.
- Smoking more than 25 cigarettes per day.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Sub-Investigator. contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
- 50 mL to 300 mL of whole blood within 30 days,
- 301 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Subjects with diabetes (including diabetes mellitus).
- Subjects with known serious hepatic impairments.
- Subjects with clinically significant presence or history of hypoglycemia.
Additional exclusion criteria for females only:
- Breast-feeding subject.
- Positive urine pregnancy test at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Glimepiride
Glimepiride tablets 1 mg of Dr. Reddy's Laboratories Limited
|
Other Names:
|
ACTIVE_COMPARATOR: Amaryl
Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fed condition
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (ACTUAL)
December 1, 2003
Study Completion (ACTUAL)
December 1, 2003
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (ESTIMATE)
January 21, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 21, 2010
Last Update Submitted That Met QC Criteria
January 19, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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