SYNOPSIS. Final Clinical Study Report for Study CV Final Clinical Study Report

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1 Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Individual Study Table Referring to the Dossier (For National Authority Use Only) Name of Active Ingredient: Saxagliptin SYNOPSIS for Study TITLE OF STUDY: Bioequivalence Study of a 1 x 1000-mg Tablet Relative to 2 x 500-mg Tablets in Healthy Subjects in a Fed Condition INVESTIGATORS/STUDY CENTERS: John Coumbis, MD, Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, NJ PUBLICATIONS: None STUDY PERIOD: Study Initiation Date: 28-Aug-2008 CLINICAL PHASE: 1 Study Completion Date: 24-Oct-2008 OBJECTIVES: The primary objective was to demonstrate bioequivalence of the metformin XR 1 x 1000-milligram (mg) tablet with metformin XR 2 x 500-mg tablets in fed healthy subjects. The secondary objective was to summarize the safety and tolerability of metformin XR when administered as 2 x 500-mg tablets and when administered as a 1 x 1000-mg tablet. METHODOLOGY: This was an open-label, randomized, 2-period, 2-treatment, crossover study in healthy fed subjects. Subjects underwent screening evaluations to determine eligibility within 21 days prior to study enrollment. Subjects were admitted to the clinical facility on Day -1, the day prior to dosing (Day 1 of Period 1), and were kept in-house until study discharge (Day 3 of Period 2). Subjects were randomized to receive the following 2 treatments, after consuming a standard meal, in 1 of 2 treatment sequences:

2 Figure 1: Study Design S R Treatment A a or Treatment B b W Treatment A a or Treatment B b D Day -21 to Day 1 Day 1 to Day 3 (PK 48 hr) PERIOD 1 PERIOD 2 Day 4 to ~Day 7 Day 1 to Day 3 (PK 48 hr) Day 3 a A single evening dose of metformin XR 2 x 500-mg tablets, by mouth (PO) (reference therapy) b A single evening dose of metformin XR 1 x 1000-mg tablet, PO (test therapy) Abbreviations: hr = hours, PK = pharmacokinetics, S = Screening; R = Randomization; W = at least a 7-day Washout; D = Study Discharge NUMBER OF SUBJECTS (Planned and Analyzed): A total of 12 subjects were needed to conclude bioequivalence in this study. In order to allow for dropouts and including 4 replacement subjects (see Sample Size Determination for further details), a total of 18 were randomized, treated, and analyzed for safety. Thirteen (13) subjects were evaluable for PK. MAIN CRITERIA FOR INCLUSION: Healthy subjects who fulfilled the inclusion and exclusion criteria were eligible for this study. TEST PRODUCT, DOSE AND MODE OF ADMINISTRATION, DURATION OF TREATMENT, BATCH NUMBERS: After a 6-hour fast, subjects randomized to the test product received a single dose of metformin XR 1 x 1000-mg tablets, PO (Treatment B), after a standard meal. The batch product and batch label numbers for metformin hydrochloride XR 1000-mg tablets were 8C45687 and 8G37444, respectively. REFERENCE THERAPY, DOSE AND MODE OF ADMINISTRATION, DURATION OF TREATMENT, BATCH NUMBERS: After a 6-hour fast, subjects randomized to the reference therapy received a single dose of metformin XR 2 x 500-mg tablets, PO (Treatment A) after a standard meal. The batch product and batch label numbers for Glucophage XR tablets were 8C38397 and 8F32319, respectively. Since metformin XR was administered in healthy subjects in this study, both reference and test treatments in both periods were given with 240 ml of a 20% glucose solution in water, followed by 60 ml of the glucose solution every 15 minutes for 4 hours after dosing as recommended in the United States Food and Drug Administration (FDA) draft guidance for metformin XR bioequivalence studies. CRITERIA FOR EVALUATION: Safety: Safety assessments were based on medical review of adverse event (AE) reports (including intercurrent illness) and the results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests. Pharmacokinetics: Single-dose pharmacokinetics (PK) parameters [Cmax, Tmax, AUC(0-T), AUC(INF), and T-HALF] of metformin were derived from plasma concentration versus time data.

3 STATISTICAL CONSIDERATIONS: Sample Size Determination If there was no difference between the bioavailabilities of metformin XR 1 x 1000-mg tablet versus metformin XR 2 x 500-mg tablets, then 12 subjects would have provided 95% and 99% power to conclude bioequivalence with respect to Cmax and AUC(INF), respectively. If the actual difference was 5%, then 12 subjects would have provided 87% and 99% power to conclude bioequivalence with respect to Cmax and AUC(INF), respectively. These calculations assumed that Cmax and AUC(INF) were log normally distributed with intra-subject standard deviations of and for log(cmax) and log[auc(inf)], respectively. At least 12 evaluable subjects were required to conclude bioequivalence. In order to allow for dropouts and including 4 replacement subjects, a total of 18 subjects were randomized and treated. The 4 subjects were enrolled to replace 2 (11%) subjects who had discontinued due to withdrawal of consent and 2 other subjects who completed the study, but had consumed non-standard meals. The primary PK outcome measures were Cmax and AUC(INF). According to the current FDA Guidance for Industry, bioequivalence would have been concluded if the 90% confidence intervals (CI) for the ratios of geometric means of test formulation to reference formulation were contained within 80% to 125% for both Cmax and AUC(INF). Statistical Analyses All recorded AEs were listed and tabulated by system organ class, preferred term and treatment. Vital signs and clinical laboratory test results were listed and summarized by treatment. Any significant physical examination findings and clinical laboratory results were listed. ECG readings were evaluated by the Investigator and abnormalities, if present, were listed. To demonstrate the bioequivalence of metformin XR 1 x 1000-mg tablet versus metformin XR 2 x 500-mg tablets, analyses of variance (ANOVA) were performed on log[auc(inf)], log[auc(0-t)], and log(cmax) of metformin. The factors in the analyses were sequence group, subject within sequence, period, and treatment. Since subjects were random effects nested within sequences, F-statistics for sequence effects were the ratios of the type I mean squares for sequence and subjects within sequence. Point estimates and 90% CIs for the treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustments were made for multiplicity. SUMMARY OF RESULTS: Disposition and Baseline/Demographic Characteristics: A total of 18 subjects were randomized and received study medication. Two subjects (11%) discontinued from the study because they withdrew their consent to participate. Of these 2 subjects, 1 received only Treatment A and the other received only Treatment B. A total of 4 additional subjects were enrolled to replace the 2 who had discontinued and 2 other subjects who completed the study, but had consumed non-standard meals. Table 1 summarizes subject disposition. Table 1: Subject Disposition All Subjects (N = 18) Total No. of Subjects Randomized, treated 18 No. of Subjects Completed (includes 4 replacement subjects) 16 No. of Subjects Discontinued, dosed 2 Withdrew consent 2

4 Table 2 lists the baseline and demographic characteristics of all 18 treated subjects (includes the 4 replacement subjects). Table 2: Demographic Characteristics and Physical Measurements for Treated Subjects All Subjects Characteristic N = 18 a Age (years) Mean (SD) 33 (8) Range Gender, n (%) Male 16 (89) Female 2 (11) Race, n (%) White 8 (44) Black 8 (44) Other 2 (11) Weight (kg) Mean (SD) 82.4 (12.7) Range Height (cm) Mean (SD) (9.6) Range Body Mass Index (kg/m 2 ) Mean (SD) 26.5 (2.8) Range Abbreviations: cm = centimeter, kg = kilogram, m = meter, SD = standard deviation

5 Safety Results: There were no deaths, serious adverse events (SAEs), or discontinuations due to AEs in this study. Table 3 summarizes the number of subjects with AEs that counted for all treated subjects. Table 3: Number (Percentage) of Subjects with Adverse Events That Counted, by SOC, Preferred Term, and Treatment Group for Treated Subjects System Organ Class Preferred Term 2 x 500 mg (n=17) a Number (Percent) of Subjects 1 x 1000 mg (n=17) b All Subjects (n=18) Skin Disorders Rash Gastrointestinal Disorders Nausea Lower abdominal pain Diarrhea Dyspepsia Flatulence Vomiting 2 (11.8) 2 (11.1) General Disorders Chest discomfort Musculoskeletal Disorders Back Pain Nervous System Disorders Burning Sensation Headache Respiratory Disorders Nasal Congestion Oropharyngeal Pain 2 (11.8) 3 (16.7) Total Events c Total Subjects 6 (35.3) 4 (23.5) 8 (44.4) a Subject did not receive metformin XR 2 x 500 mg because he withdrew his consent to participate. b Subject -1-4 did not receive metformin XR 1 x 1000 mg because she withdrew her consent to participate. c Total events may exceed the total subjects or the sum of subjects with events in the treatment group because some subjects reported more than 1 event categorized under more than 1 body system and/or because a single subject may have reported more than 1 event within the same body system.

6 Pharmacokinetic Results: The summary statistics for metformin PK parameters are presented in Table 4. Table 4: Summary Statistics for Metformin Pharmacokinetic Parameters Pharmacokinetic Parameter AUC(INF) (ng/ml h) Geometric Mean (CV %) AUC(0-T) (ng/ml h) Geometric Mean (CV %) Cmax (ng/ml) Geometric Mean (CV %) Tmax (hours) Median (Min, Max) T-HALF (hours) Mean (SD) 2 x 500 mg (n=13) Treatments 1 x 1000 mg (n=13) 9595 (16) 9719 (20) 9451 (16) 9582 (20) 736 (18) 858 (24) (4.00, 12.00) (3.98, 12.00) 8.11 (2.28) 7.89 (2.65) Note: Subjects -1-1 and -1-2 were excluded due to consumption of a non-standard meal, Subjects -1-4 and were excluded due to incomplete data (withdrew consent and did not complete the study), and Subject was excluded due to vomiting within 2 times the median Tmax for metformin XR. Table 5 summarizes the statistical analyses on metformin Cmax, AUC(INF), and AUC(0-T). Table 5: Results of Statistical Analyses on Metformin Cmax, AUC(INF) and AUC(0-T) Pharmacokinetic Parameter Adjusted Geometric Means 2 x 500 mg 1 x 1000 mg B/A a Ratio of Adjusted Geometric Means Point Estimate 90% C.I. AUC(INF) (ng/ml h) (0.965, 1.067) AUC(0-T) (ng/ml h) (0.966, 1.068) Cmax (ng/ml) (1.037, 1.323) a B/A = metformin XR 1 x 1000-mg tablet/metformin XR 2 x 500-mg tablets Note: Subjects -1-1 and -1-2 were excluded due to meal deviations, Subjects -1-4 and were excluded due to incomplete data (withdrew consent and did not complete the study), and Subject was excluded due to vomiting within 2 times the median Tmax for metformin XR. Based upon results presented in the above table, the comparisons of metformin XR 1 x 1000-mg tablet (test) to metformin XR 2 x 500-mg tablets (reference) have met the usual criteria for bioequivalence with

7 respect to AUC(INF) and AUC(0-T) of metformin. However, the Cmax was increased by 17% with the 1 x 1000-mg tablet, and the 90% CI for the ratio of Cmax geometric means extended above the bioequivalence interval of 80% to 125%. No sequence or period effects were statistically significant in any of the above analyses. CONCLUSIONS: The bioequivalence of a metformin XR 1 x 1000-mg tablet relative to metformin XR 2 x 500-mg tablets in fed healthy subjects was demonstrated with respect to AUC(INF) and AUC(0-T) The Cmax of metformin XR 1 x 1000 mg was 17% higher relative to that observed for metformin XR 2 x 500 mg and did not meet the pre-specified criteria for bioequivalence with respect to Cmax (90% CIs within 80% to 125%); however, the difference in Cmax was considered to be of no clinical consequence supporting the finding of dose strength equivalence between the 2 x 500 mg and 1 x 1000 mg formulations on the basis of AUC alone 1000 mg was generally safe and tolerated when administered as either metformin XR 2 x 500 mg or metformin XR 1 x 1000 mg DATE OF REPORT: 10-Aug-2009

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