The DDI Study of SP2086 and Valsartan

NCT ID: NCT02817217

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SP2086 and Valsartan

Group Type OTHER

SP2086

Intervention Type DRUG

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.

Valsartan

Intervention Type DRUG

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.

Interventions

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SP2086

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.

Intervention Type DRUG

Valsartan

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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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People's Liberation Army General Hospital of Chengdu Military Region

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaolan Yong, docter

Role: primary

028-86571275

Other Identifiers

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SP2086-111

Identifier Type: -

Identifier Source: org_study_id

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