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

NCT02821871 | Unknown Phase 1

• 1 other identifier: SP2086-110
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to Day 12

Study Arms (2)

SP2086

ACTIVE COMPARATOR

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

high fat diet

OTHER

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

Interventions

SP2086 DRUG

high fat diet

high fat diet DIETARY_SUPPLEMENT

SP2086

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Yanhua Ding, docter

CONTACT

0431-88782168; dingyanhua2003@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 4, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

CN (1)