Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition

NCT01053689 | Completed Phase 1 DMC

• 1 other identifier: 30287
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence, Glimepiride, Crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fed condition

  5 months

Study Arms (2)

Glimepiride

EXPERIMENTAL

Glimepiride tablets 1 mg of Dr. Reddy's Laboratories Limited

Drug: Glimepiride tablets 1 mg

Amaryl

ACTIVE COMPARATOR

Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc

Drug: Glimepiride tablets 1 mg

Interventions

Glimepiride tablets 1 mg DRUG

Also known as: Amaryl

Amaryl; Glimepiride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm Inc

Sainte-Foy, Quebec, GIV 2KB, Canada

Location

MeSH Terms

Interventions

glimepiride

Study Officials

• Benoit Girard, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: December 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

CA (1)