The Metabolite Identification and Material Balance Study of SP2086

Study Overview
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Brief Summary
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The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Detailed Description
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All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Official Title
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A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SP2086


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg. Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible. Had signed the informed consent himself or herself voluntarily. Exclusion Criteria: Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.). Has a history of allergy or intolerance to SP2086 OR other DPP-IV. The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks. Did not take effective contraceptive measures or planning of the subjects in half a year. Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SP2086<br>SP2086 was taken only one time at 100mg dose in health volunteers | Drug: SP2086<br>* SP2086 was taken only one time at 100mg dose in health volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) of SP2086 | Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours | 
| The maximum plasma concentration (Cmax) of SP2086 acid | Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours | 
| The area under the plasma concentration-time curve (AUC) of SP2086 | AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours | 
| The area under the plasma concentration-time curve (AUC) of SP2086 acid | AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086 | up to 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SP2086, Metabolite identification, Material balance