Bioequivalence of One Tablet of Gliclazide MR 90 mg (S005190) and One and a Half Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fed Conditions.
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Study description
Diabetes is a disease that occurs when the levels of blood sugar are too high. In type 1 diabetes, the body doesn’t make insulin (the hormone that lowers the level of sugar in the blood). In type 2 diabetes, the body doesn’t make enough insulin or can’t use it as well as it should.
Gliclazide is a family of medicines that reduces blood sugar levels. It is used in adults with type 2 diabetes, when diet, exercise, and weight loss alone are not enough to keep blood sugar at the correct level.
Gliclazide is available in Europe and in many other countries around the world. It is available under several names including Diamicron® modified release (MR) 30 milligrams (mg) and 60 mg. An MR tablet means that the active drug is released over several hours to maintain a constant amount of the drug in the blood.
The daily dose of gliclazide may vary from 30 mg to 120 mg. Currently, patients requiring 90 mg take one and a half tablets of gliclazide MR 60 mg at breakfast time. The availability of a 90 mg tablet would simplify treatment. This may help patients to stick to their treatment. For this purpose, researchers are developing a new MR tablet containing 90 mg of gliclazide.
The aim of this study was to see if one tablet of gliclazide MR 90 mg was processed by the bodies of healthy participants in the same way as one and a half tablets of Diamicron® MR 60 mg tablets.
Blood samples were collected from the participants to check how gliclazide was absorbed into their bodies and moved through their blood. This is called “bioavailability”. In this study, bioavailability was tested after eating a meal (fed conditions).
- Gliclazide
- Diamicron
- S005190-205
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
YesTo take part, participants had to be:
- Men or women between 18 to 50 years of age.
- Healthy with no previous history of certain diseases.
- Non-smokers for at least 3 months before starting the study.
Participants were not included in the study if they had:
- Any major surgery within a month of starting the study or planning to have surgery during the study.
- Known allergy to any of the substances in the study drug or any other drug.
How is the study designed?
Participants were divided into 2 groups. Each group received the 2 treatments (gliclazide MR 90 mg and Diamicron® MR 60 mg) but in a different order.
Participants took the study drugs by mouth as instructed by the study staff. They took the study drug as a single dose, 30 minutes after starting their breakfast.
Gliclazide MR 90 mg tablet is the test drug that the researchers wanted to learn more about.
Diamicron® MR 60 mg tablets (containing 60 mg of gliclazide) are used as the reference drug to compare against the new gliclazide MR 90 mg tablets.
Participants were divided into 2 groups. Each group received the 2 treatments (gliclazide MR 90 mg and Diamicron® MR 60 mg) but in a different order.
Participants took the study drugs by mouth as instructed by the study staff. They took the study drug as a single dose, 30 minutes after starting their breakfast.
Gliclazide MR 90 mg tablet is the test drug that the researchers wanted to learn more about.
Diamicron® MR 60 mg tablets (containing 60 mg of gliclazide) are used as the reference drug to compare against the new gliclazide MR 90 mg tablets.