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

Phase 1

• Conditions: Type 2 Diabetes
• Interventions: Drug: SP2086; Dietary Supplement: high fat diet

• Registration Number: NCT02821871
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-06
• Study First Submitted: 2016-06-26
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-07-04
• Last Update Posted: 2016-07-04
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
high fat diet	SP2086	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.
SP2086	high fat diet	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.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SP2086 acid	up to Day 12	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in fecal	up to Day 12
The maximum plasma concentration (Cmax) of SP2086	up to Day 12	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid	up to Day 12	AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
The area under the plasma concentration-time curve (AUC) of SP2086	up to Day 12	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in urine	up to Day 12

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 12

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China