The Metabolite Identification and Material Balance Study of SP2086

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

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.

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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.

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

SP2086 was taken only one time at 100mg dose in health volunteers

Group Type OTHER

SP2086

Intervention Type DRUG

SP2086 was taken only one time at 100mg dose in health volunteers

Interventions

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SP2086

SP2086 was taken only one time at 100mg dose in health volunteers

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes