| Primary | Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
| | Units | Counts |
|---|
| Participants | - OG00024
- OG00124
- OG00223
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00049.23± 18.52
- OG00149.94± 19.72
- OG00252.50± 17.95
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. | | | | | Ratio (%) of Geometric LS Means | 101.45 | | | 2-Sided | 90 | 98.17 | 104.84 | | | Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares. | Yes |
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| Secondary | 5-hydroxy Saxagliptin PK Parameter AUC(0-inf) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. | All treated participants not discontinuing prior to the end of the study. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
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| Secondary | 5-hydroxy Saxagliptin PK Parameter Cmax | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma. | All treated participants not discontinuing prior to the end of the study. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
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| Primary | Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
|
| Primary | Metformin PK Parameter AUC(0-inf) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
|
| Primary | Metformin PK Parameter Cmax | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma. | All treated participants not discontinuing prior to the end of the study. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition. | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition. | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition. |
|
| Secondary | 5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. | All treated participants not discontinuing prior to the end of the study. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
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| Secondary | 5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma. | All treated participants not discontinuing prior to the end of the study. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
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| Secondary | 5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. | All treated participants not discontinuing prior to the end of the study. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
|
| Secondary | Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs). | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | All participants who received at least one dose of study medication. | Posted | | Number | | participants | | AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening). | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | |
|
| Other Pre-specified | Saxagliptin PK Parameter AUC(0-t) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
|
| Other Pre-specified | Saxagliptin PK Parameter T1/2 | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
|
| Other Pre-specified | Saxagliptin PK Parameter Tmax | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | |
|
| Other Pre-specified | Metformin PK Parameter AUC(0-t) | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. | All treated participants not discontinuing prior to the end of the study. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
|
| Other Pre-specified | Metformin PK Parameter T1/2 | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma. | All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D |
|
| Other Pre-specified | Metformin PK Parameter Tmax | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. | All treated participants not discontinuing prior to the end of the study. | Posted | | Mean | Standard Deviation | hr | | Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
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| Secondary | Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities | Abnormalities that were considered clinically significant and/or reported as an AE by the investigator. | All participants who received at least one dose of study medication. | Posted | | Number | | participants | | From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening). | | | | ID | Title | Description |
|---|
| OG000 | Treatment A | 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition | | OG001 | Treatment B | Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition | | OG002 | Treatment C | 2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition | | OG003 | Treatment D | FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition |
|