Bioequivalence Study of 4 mg Glimepiride Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01677247
First received: August 29, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).


Condition Intervention
Glimepiride BE Study in Healthy Volunteers Under Fasting Condition
Drug: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica
Drug: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition.


Secondary Outcome Measures:
  • Bioavailability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Relative bioavailability (secondarily measured by tmax and t1/2) between two formulations of glimepiride 4 mg tablets (the Test and Reference formulations)

  • Adverse events [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
    The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month).


Enrollment: 24
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (Test)
Test : glimepiride 4 mg tablet of PT Dexa Medica
Drug: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica
In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
Active Comparator: Group II (Reference)
Reference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia
Drug: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
Other Name: Amaryl®, manufactured by PT Sanofi Aventis

Detailed Description:

The participating subjects were required to have an overnight fast; and in the next morning they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference drug with 200 mL water.

Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5, 2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out period), the procedure was repeated using the alternate drug.

The plasma concentrations of glimepiride were determined by high performance liquid chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed are AUCt, AUCinf, Cmax, tmax, and t1/2.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
  2. Age of 18 - 55 years
  3. Preferably non-smokers or moderate smokers (less than 10 cigarettes per day)
  4. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
  5. BMI 18 - 25 kg/m2
  6. Vital signs (after 10 minutes rest) must be within the following ranges:

    • SBP 100 - 120 mmHg
    • DBP 60 - 80 mmHg
    • Pulse rate 60 - 90 bpm

Exclusion Criteria:

  1. Personal/family history of allergy or hypersensitivity or contraindication to glimepiride or allied drugs
  2. Pregnant or lactating women
  3. Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness
  4. Presence of any clinically significant abnormal values during screening
  5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
  6. Clinically significant haematology abnormalities
  7. Clinically significant electrocardiogram (ECG) abnormalities
  8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug
  9. Past history of anaphylaxis or angioedema
  10. History of drug or alcohol abuse within 12 months prior to screening
  11. Participation in any clinical trial within the past 90 days
  12. History of any bleeding or coagulative disorders
  13. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
  14. A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
  15. Intake of any prescription, non-prescription drug, food supplements or herbal medicines within 14 days of this study's first dosing day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677247

Locations
Indonesia
PT Equilab International
Jakarta, Indonesia, 12430
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Danang A. Yunaidi, MD PT Equilab International
  More Information

Publications:
Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01677247     History of Changes
Other Study ID Numbers: BE-Glimepiride
Study First Received: August 29, 2012
Last Updated: August 30, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
sulphonylurea
anti-hyperglycaemic
bioavailability
bioequivalence
glimepiride
pharmacokinetics

Additional relevant MeSH terms:
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014