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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1168-6473 | Registry Identifier | WHO |
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The purpose of this study is to determine the relative bioavailability of alogliptin 12.5 milligram (mg) and immediate-release metformin 1000 mg when administered as individual tablets and as a fixed-dose combination (FDC) product.
The drug being tested in this study is called SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg FDC tablet). SYR-322MET is being tested to assess whether its pharmacokinetic properties (how it is processed by the body) are affected when administered as a FDC compared to administration of alogliptin and metformin alone. This study will look at lab results in people who take SYR-322MET.
This crossover study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment sequences. All participants will receive both treatments over two periods; the order of receipt will be determined by the randomization code. All participants will receive the following study medications by the end of the study:
This single center trial will be conducted in Russia. The overall time to participate in this study is up to 63 days. Participants will make multiple visits to the clinic including two 4-day periods of confinement to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence I: AB | Experimental | SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by alogliptin 12.5 mg tablets and metformin 1000 mg tablets, orally, once, on Day 1 of Period 2. |
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| Sequence II: BA | Experimental | Alogliptin 12.5 mg tablets, orally and metformin 1000 mg tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin 12.5 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alogliptin | (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]). | Day 1 predose and at multiple time points (up to 72 hours) post-dose. |
| Cmax: Maximum Observed Plasma Concentration for Alogliptin | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 1 predose and at multiple time points (up to 72 hours) post-dose. |
| AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin | (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]). | Day 1 predose and at multiple time points (up to 72 hours) post-dose. |
| Cmax: Maximum Observed Plasma Concentration for Metformin | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 1 predose and at multiple time points (up to 72 hours) post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Experience at Least one Post-dose Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
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| ID | Term |
|---|---|
| C520853 | alogliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin Hydrochloride | Drug | Metformin hydrochloride 1000 mg tablets |
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| SYR-322MET | Drug | SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets |
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| Day 1 of Period 1 up to 30 days after the last dose of study medication (up to 38 days) |
| Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | Standard safety laboratory values (hematology and chemistry) will be collected throughout study and compared to pre-specified criteria for markedly abnormal values. | At Day 4 and Day 7 of Period 2 |
| Percentage Of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Vital sign measurements will be collected throughout study and compared to pre-specified criteria for markedly abnormal values. | Day 1 up to Day 4 of each period |
| Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose | Standard 12-lead ECG measurements will be collected throughout the study and compared to pre-specified criteria for markedly abnormal values. | At Day 1 and Day 4 of each period |