the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers

Study Overview
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Brief Summary
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All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SP2086
* Dietary Supplement: high fat diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2 Exclusion Criteria: History of diabetes History of heart failure or renal insufficiency Urinary tract infections, or vulvovaginal mycotic infections History of or current clinically significant medical illness as determined by the Investigator History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose Known allergy to SP2086 or any of the excipients of the formulation of SP2086

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SP2086<br>All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. | Dietary Supplement: high fat diet<br> <br> |
| Other: high fat diet<br>All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. | Drug: SP2086<br> <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 a single dose of SP2086 | up to Day 12 | 
| 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 a single dose of SP2086. | up to Day 12 | 
| 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 a single dose of SP2086. | up to Day 12 | 
| 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 a single dose of SP2086. | up to Day 12 | 
| Cumulative percentage drainage of SP2086 in urine |  | up to Day 12 | 
| Cumulative percentage drainage of SP2086 in fecal |  | up to Day 12 | 

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 Day 12 |