The Drug-drug Interaction of SP2086 and Valsartan

NCT02815657 | Completed Phase 1

• 1 other identifier: HR-SP-106
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

SP2086; Valsartan; Drug-drug Interaction

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 multiple doses of SP2086

  up to Day 31

• 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 multiple doses of SP2086

  up to Day 31

• The maximum plasma concentration (Cmax) of valsartan

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

  up to Day 31

• 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 SP2086

  up to Day 31

• 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 multiple doses of SP2086

  up to Day 31

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

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

  up to Day 31

Secondary Outcomes (1)

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

  up to Day 31

Study Arms (2)

SP2086 and Valsartan

ACTIVE COMPARATOR

All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from A stage to B stage.

Drug: SP2086; Drug: Valsartan

Valsartan and SP2086

ACTIVE COMPARATOR

All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from B stage to A stage.

Drug: SP2086; Drug: Valsartan

Interventions

SP2086 DRUG

The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12

SP2086 and Valsartan; Valsartan and SP2086

Valsartan DRUG

The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12

SP2086 and Valsartan; Valsartan and SP2086

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
• Had signed the informed consent himself or herself.

You may not qualify if:

• Have the abnormal lab or other examination results and the change have clinical significance.
• History of or current clinically significant medical illness as determined by the Investigator.
• Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome
• Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
• History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
• History of severe unconsciousness hypoglycemia
• History of any surgery prior to screening in 6 months.
• History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
• History of participate any drug or medical device prior to screening in 3 months.
• Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
• days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
• The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
• Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
• Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

People's Liberation Army General Hospital of Chengdu Military Region

Chengdu, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Valsartan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• XiaoLan Yong, P.H.D

  People's Liberation Army General Hospital of Chengdu Military Region

  PRINCIPAL INVESTIGATOR

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: January 3, 2016
• First Posted: June 28, 2016
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

CN (1)