The Drug-drug Interaction of SHR3824 and SP2086

NCT02500485 | Unknown Phase 1

• 1 other identifier: SHR3824-106
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.

Conditions

Type 2 Diabetes

Keywords

SHR3824 SP2086 drug-drug interaction

Outcome Measures

Primary Outcomes (5)

• The maximum plasma concentration (Cmax) of SHR3824.

  Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.

  At protocol-specified times up to Day 14 and Day 18.

• The area under the plasma concentration-time curve (AUC) of SHR3824.

  AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.

  At protocol-specified times up to Day 14 and Day 18.

• 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 multiple doses of SHR3824

  At protocol-specified times up to Day 4 and Day 18.

• 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 multiple doses of SHR3824.

  At protocol-specified times up to Day 4 and Day 18.

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

  Up tp day 18.

Study Arms (1)

SHR3824 20mg/SP2086 100mg

EXPERIMENTAL

One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.

Drug: SHR3824, SP2086

Interventions

SHR3824, SP2086 DRUG

One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.

Also known as: Henagliflozin, Retagliptin

SHR3824 20mg/SP2086 100mg

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 24 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 SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Haiyan Liu, PhD

CONTACT

+86-15705155025; liuhaiyan@shhrp.com

Study Design

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

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 16, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-07

Locations

CN (1)