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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: high fat diet; Drug: SP2086

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanhua Ding, docter; Phone Number: 0431-88782168; Email: dingyanhua2003@126.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Haichun Ma, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: high fat diet
Other: 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.	Drug: SP2086

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: June 26, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SP2086-110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No