Bioequivalence Study of 4 mg Glimepiride Tablet

Dexa Medica

Status: Completed

Conditions: Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Treatments: Drug: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis; Drug: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica

Study type: Interventional

Funder types: Industry

Identifiers

NCT01677247

BE-Glimepiride

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Group I (Test)

Experimental group

Description:

Test : glimepiride 4 mg tablet of PT Dexa Medica

Treatment:

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

Group II (Reference)

Active Comparator group

Description:

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

Treatment:

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