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Gliclazide 30 rvg 3459

BIOAVAILABILITY OF GLICLAZIDE*
PROLONGED RELEASE TABLETS, 30 MG
RVG 34591
INTRODUCTION
Gliclazide is a hypoglycaemic sulphonylurea derivative which is indicated for type 2 diabetes mellitus uncontrolled by diet, exercise and weight loss. It can be used as monotherapy or in combination with for example metformin and insulin. Gliclazide, similar as other sulfonylurea derivatives, stimulates insulin secretion from the pancreatic ß-cells by closing ATP-sensitive potassium channels. Insulin sensitivity also Gliclazide is progressively released from the tablets upon contact with gastrointestinal fluid. Gliclazide prolonged release tablets show predictable and reproducible release of gliclazide over a 24-hour period which parallels the 24-hour glycaemic profile observed in untreated patients with diabetes mellitus type 2. Plasma concentrations reach a plateau at 3 to 12 hours after dose. The mean absolute bioavailability of gliclazide is 97%. Gliclazide is highly bound to albumin (95%). It is extensively metabolized to at least seven metabolites. The plasma elimination half life is about 16 hours. Three bioequivalence studies with healthy volunteers, one study in fasting conditions (study 1), one in post-prandial conditions (study 2) and a study comparing steady state conditions (study 3), were performed to confirm bioequivalence between the test (Gliclazide 30 PCH) and the reference product (Diamicron UNO 30 mg, Servier GmbH). * Based on a registration study approved by CBG-MEB STUDY 1 BIOEQUIVALENCE STUDY WITH GLICLAZIDE UNDER FASTING
CONDITIONS
EXPERIMENTAL PART
This study was conducted in compliance with Good Clinical Practice (GCP). Thirty-six healthy volunteers participated in this study and thirty-six subjects completed the study. The study was designed as a two period, cross-over, controlled, block randomized, single-dose bioequivalence study. A fasting period of at least 10 hours was established. The study consisted of two treatment periods separated by a wash-out period of 14 days. In each treatment period each healthy subject received a single dose (1 x 30 mg) of the test or reference product in accordance with the randomization scheme. Blood samples were collected before dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 16.0, 20.0 and 24.0, 36.0, 48.0, 60.0, 72.0, 96.0 and 120.0 hours post dosing in each of the two periods. Plasma samples from all thirty-six subjects were analyzed. MEASUREMENTS
The concentration of gliclazide was analyzed in the collected blood samples and the following pharmacokinetic parameters were determined: AUC0-t ; AUC0-∞ ; Cmax secondary; AUC%extra; T½; MRT as additional parameters. The 90% confidence intervals were constructed for test/reference ratios of the means of the pharmacokinetic parameters AUC0-t, AUC0-∞ , Cmax. Bioequivalence was concluded if these confidence intervals fell within the Thirty-six volunteers completed the study. The pharmacokinetic parameters are reflected in Table 1. The mean plasma concentrations of gliclazide measured after administration of the test product and reference product are reflected in Figure 1. The 90% confidence intervals of the mean ratio (test/reference) were within the acceptance No serious adverse events were observed during the conduct of this study. Table 1: Primary pharmacokinetic parameters of test and reference product
Parameter
Geometric means
90% Confidence
geometric
Interval
Reference
AUC0-t (ng/ml * h)
AUC0-(ng/ml * h)
Cmax (ng/ml)
Figure 1: Mean plasma concentration – time profile of gliclazide after oral administration of
30 mg test and reference product, log scale. STUDY 2 BIOEQUIVALENCE STUDY WITH GLICLAZIDE UNDER FED
CONDITIONS
EXPERIMENTAL PART
This study was conducted in compliance with Good Clinical Practice (GCP). Thirty-six healthy volunteers participated in this study and thirty-five subjects completed the study. The study was designed as a two period, cross-over, controlled, block randomized, single-dose bioequivalence study. The study consisted of two treatment periods separated by a wash-out period of 18 days. In each treatment period each healthy subject received a single dose (1 x 30 mg) of the test or reference product after a high-fat breakfast in accordance with the randomization scheme. Blood samples were collected before dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 16.0, 20.0, 24.0, 36.0, 48.0, 60.0, 72.0, 96.0 and 120.0 hours post dosing in each of the two periods. Plasma samples from thirty-five subjects MEASUREMENTS
The concentration of gliclazide was analyzed in the collected blood samples and the following primary pharmacokinetic parameters were determined to assess bioequivalence: AUC0-t ; AUC0-∞ ; Cmax as primary; Tmax as secondary; AUC%extra; T½; MRT as additional parameters. The 90% confidence intervals were constructed for test/reference ratios of the means of the pharmacokinetic parameters AUC0-t, AUC0-∞ , Cmax. Bioequivalence was concluded if these confidence intervals fell within the range of 80-125%. Thirty-five volunteers completed the study. The pharmacokinetic parameters are reflected in Table 2. The mean plasma concentrations of gliclazide measured after administration of the test product and reference product are reflected in Figure 2. The 90% confidence intervals of the mean ratio (test/reference) were within the acceptance No serious adverse events were observed during the conduct of this study. Table 2: Primary pharmacokinetic parameters of test and reference product
Parameter
Geometric means
90% Confidence
geometric
Interval
Reference
AUC0-t (ng/ml * h)
AUC0-(ng/ml * h)
Cmax (ng/ml)
Figure 2: Mean plasma concentration – time profile of gliclazide after oral administration of
30 mg test and reference product under fed conditions, log scale. STUDY 3 BIOEQUIVALENCE STUDY AT STEADY STATE WITH GLICLAZIDE
EXPERIMENTAL PART
This study was conducted in compliance with Good Clinical Practice (GCP). Thirty-six healthy volunteers participated in this study and thirty-six subjects completed the study. The study was designed as a two period, cross-over, controlled, block randomized, multiple dose (at steady state) bioequivalence study. The study consisted of two treatment periods separated by a wash-out period of 16 days. In each treatment period each healthy subject received a dose (1 x 30 mg) of the test or reference product for six consecutive days in accordance with the randomization scheme. Blood samples were collected before dosing for days 1-6 and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 20.0 and 24.0 hours post dosing for day 6 in each of the two periods. Plasma samples from thirty-six MEASUREMENTS
The concentration of gliclazide was analyzed in the collected blood samples and the following pharmacokinetic parameters were determined: AUCss; Cmaxss as primary; Tmax as secondary; Cminss; %ptf; %Swing; Caverage as additional parameters. The 90% confidence intervals were constructed for test/reference ratios of the means of the pharmacokinetic parameters AUCss and Cmaxss. Bioequivalence was concluded if these confidence intervals fell within the range Thirty-six volunteers completed the study. The pharmacokinetic parameters are reflected in Table 3. The mean plasma concentrations of gliclazide measured after administration of the test product and reference product are reflected in Figure 3. The 90% confidence intervals of the mean ratio (test/reference) were within the acceptance No serious adverse events were observed during the conduct of this study. Table 3: Primary pharmacokinetic parameters of test and reference product
Parameter
Geometric means
90% Confidence
geometric
Interval
Reference
AUCss (ng/ml * h)
Cmaxss (ng/ml)
Figure 3: Mean plasma concentration – time profile of gliclazide after oral administration of
30 mg test and reference product at steady state, log scale. CONCLUSION
Both formulations were well tolerated, with no major side effects and no relevant differences in The time concentration profile of Gliclazide 30 PCH was very similar to that of reference product. Using the evaluation criteria described previously, the parameters Cmax, AUC0-t and AUC0-∞ and AUCss and Cmaxss fulfil the requirements for bioequivalence. It can be concluded that Gliclazide 30 PCH is bioequivalent to the reference product under fasting and fed conditions, in terms of both extent and rate of absorption and at steady state.

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