Type 2 DiabetesPhase 1NCT02815657
The Drug-drug Interaction of SP2086 and Valsartan
A Phase 1 study testing SP2086 and Valsartan in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SP2086 and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself.
Who cannot join
- 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
Show all 14Show fewer
- 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).
- 2 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.
Trial locations and contacts
1 site in 1 country.
China1 site
People's Liberation Army General Hospital of Chengdu Military Region
Chengdu
About this study
Official title: A Single Randomized, Open,Cross-over, Phase I Study to Access the Drug-drug Interaction of SP2086 and Valsartan
The purpose of the study is to investigate the potential interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy adult volunteers.
Read the detailed description
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Valsartan in healthy adult volunteers. 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.
- Conditions
- Type 2 Diabetes
- Being tested
- SP2086, Valsartan
- Keywords
- SP2086, Valsartan, Drug-drug Interaction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP2086Drug
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
ValsartanDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SP2086; Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to Day 31
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XiaoLan Yong, P.H.D, Principal investigator, People's Liberation Army General Hospital of Chengdu Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815657
- Sponsor's protocol ID
- HR-SP-106
- Status last verified
- Jun 2016
- First submitted
- 3 Jan 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Randomized, Open,Cross-over, Phase I Study to Access the Drug-drug Interaction of SP2086 and Valsartan
- ClinicalTrials.gov ID
- NCT02815657
- Acronym / sponsor ID
- HR-SP-106
- Conditions
- Type 2 Diabetes
- Keywords
- SP2086, Valsartan, Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the potential interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy adult volunteers.
Detailed description
This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Valsartan in healthy adult volunteers. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP2086 and Valsartan | Active comparator | Drug: SP2086, Drug: ValsartanAll 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. |
| Valsartan and SP2086 | Active comparator | Drug: SP2086, Drug: ValsartanAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- Had signed the informed consent himself or herself.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP2086The 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 | Drug | SP2086 and Valsartan, Valsartan and SP2086 |
| ValsartanThe 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 | Drug | SP2086 and Valsartan, Valsartan and SP2086 |
Primary outcome
The maximum plasma concentration (Cmax) of SP2086
Time frame: up to Day 31
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to Day 31
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of valsartan
Time frame: up to Day 31
Cmax (a measure of the body's exposure to valsartan) will be compared before and after administration of multiple doses of valsartan
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to Day 31
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to Day 31
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of valsartan
Time frame: up to Day 31
AUC (a measure of the body's exposure to valsartan) will be compared before and after administration of multiple doses of valsartan
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoLan Yong, P.H.D principal investigator
People's Liberation Army General Hospital of Chengdu Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP2086 and Valsartan in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) of SP2086 (time frame: up to Day 31). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.