Bioequivalence Study of 4 mg Glimepiride Tablet

NCT ID: NCT01677247

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-03-31

Brief Summary

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).

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.

Conditions

Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Keywords

pharmacokinetics; sulphonylurea; anti-hyperglycaemic; bioavailability; bioequivalence; glimepiride

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I (Test)

Test : glimepiride 4 mg tablet of PT Dexa Medica

Group Type: EXPERIMENTAL

Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica

Intervention Type: DRUG

In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.

Group II (Reference)

Reference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia

Group Type: ACTIVE_COMPARATOR

Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis

Intervention Type: DRUG

In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Amaryl®, manufactured by PT Sanofi Aventis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danang A. Yunaidi, MD

Role: PRINCIPAL_INVESTIGATOR

PT Equilab International

Locations

PT Equilab International

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

References

Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. doi: 10.1016/j.jchromb.2003.10.024.

Reference Type: BACKGROUND

PMID: 14659441 (View on PubMed)

Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.

Reference Type: BACKGROUND

PMID: 17252706 (View on PubMed)

Malerczyk V, Badian M, Korn A, Lehr KH, Waldhausl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. doi: 10.1515/dmdi.1994.11.4.341.

Reference Type: BACKGROUND

PMID: 12369757 (View on PubMed)

Other Identifiers

BE-Glimepiride

Identifier Type: -

Identifier Source: org_study_id