The DDI Study of SP2086 and Valsartan

Study Overview
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Brief Summary
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The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.

Official Title
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The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SP2086
* Drug: Valsartan


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 Valsartan or any of the excipients of the formulation of SP2086 or Valsartan

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 and Valsartan<br> | Drug: SP2086<br>* SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.<br>Drug: Valsartan<br>* SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.<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 Valsartan | up to Day 9 | 
| 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 Valsartan | up to Day 9 | 
| The maximum plasma concentration (Cmax) of Valsartan | Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086 | up to Day 9 | 
| 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 Valsartan. | up to Day 9 | 
| 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 Valsartan. | up to Day 9 | 
| The area under the plasma concentration-time curve (AUC) of Valsartan | AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086 | up to Day 9 | 

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 9 |