Diabetic NeuropathiesPhase 1NCT04841720
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK16149 Capsules and Metformin Hydrochloride Tablets
A Phase 1 study testing HSK16149, Metformin Hydrochloride tablet and HSK16149+Metformin（phase 3） in people with Diabetic Neuropathies and Diabetic Neuropathy Peripheral, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathies, Diabetic Neuropathy Peripheral
- What is being tested?
- HSK16149, Metformin Hydrochloride tablet and HSK16149+Metformin（phase 3）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 15 Aug 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years old (including 18 and 50 years old), healthy male or female;
- Weight: male ≥50 kg, female ≥45kg; body mass index (BMI) in the range of 19-28kg/m2 (including 19 and 28);
- Serum creatinine during the screening period is within the normal range, or creatinine clearance rate (CCr) ≥80mL/min;
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posterior anterior position), and laboratory examination indicators are normal or abnormal and have no clinical significance;
- Agree to have no birth plan and be able to take reliable contraceptive measures within 3 months after the end of the trial; Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent.
Who cannot join
- Those who are known to have a history of allergies, allergic diseases or allergies to the research preparation and any of its ingredients or related preparations, or those who have a history of pregabalin or gabapentin allergy;
- Those who have special requirements for diet and cannot comply with a unified diet;
- Those who have had angioedema in the past;
- Clinically significant dizziness or vertigo, or a history of inner ear diseases known to cause dizziness or vertigo;
- QTcF>450 milliseconds (msec) found in the screening period inspection;
- People with insomnia, anxiety disorder, depression disorder or other mental disorders;
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- Those who use any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the test drug, or who do not agree to prohibit the use of any caffeine-rich food or drink during the test period ；
- Any disease history or current disease that may affect the safety evaluation of subjects or the internal process of experimental drugs, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immunology, Psychiatry, metabolic abnormalities, gastrointestinal surgery (except appendicitis surgery), etc.;
- Those who donate blood or lose blood ≥400 mL or have blood transfusion within 3 months before the first administration of the test drug;
- Any drug that inhibits or induces liver drug-metabolizing enzymes (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) has been used within 30 days before the first administration of the test drug; Serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines), or Any prescription drugs, over-the-counter drugs and herbal medicines other than the above-mentioned drugs were taken within 14 days prior to the administration of the test drugs;
- Those who have participated in other drug clinical trials within 3 months before the first administration of the experimental drug;
- At this stage or have been drug users, or those who have been screened positive for drug abuse (screening items include: morphine, tetrahydrocannabinolic acid, methamphetamine, dimethylenedioxyamphetamine, Ketamine and cocaine);
- Alcoholics or frequent alcoholics in the 3 months before the test, that is, drinking more than 21 units of alcohol per week (1 unit = 360mL beer or 45 mL 40% alcoholic spirits or 150 mL wine), or alcohol exhalation Test value> 0mg/ml;
- Smokers or those who smoked more than 10 cigarettes per day within 3 months before the first administration, or who could not comply with the ban on smoking during the trial period;
- One or more of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody is positive;
- Women during pregnancy or lactation;Researchers believe that subjects have poor compliance or other factors that are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Mingxia Wang, PhD, 0331-86095794, Dgyxxli@126.com
About this study
Official title: Phase I Clinical Study to Evaluate the Drug-drug Interaction Between HSK16149 Capsules and Metformin Hydrochloride Tablets in Healthy Subjects
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
Read the detailed description
All subjects received the following drugs:
Phase 1-HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8); Phase 2-Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15); Phase 3-Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.
- Being tested
- HSK16149, Metformin Hydrochloride tablet, HSK16149+Metformin（phase 3）
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149Drug
Also called HSK16149（phase 1）
HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8);
Metformin Hydrochloride tabletDrug
Also called Metformin hydrochloride tablets（phase 2）
Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15);
HSK16149+Metformin（phase 3）Drug
Also called HSK16149 capsules and Metformin hydrochloride tablets
Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| HSK16149 | Experimental | HSK16149（D1-D5） Receives: Drug: HSK16149 |
| Metformin | Experimental | Metformin Receives: Drug: Metformin Hydrochloride tablet |
| HSK16149+Metformin | Experimental | HSK16149+Metformin Receives: Drug: HSK16149+Metformin（phase 3） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration
Measured: -30 minutes before administration until 24 hours after administration
AUC0-t, AUC0-∞
Area under the concentration-time curve
Measured: -30 minutes before administration until 24 hours after administration
Tmax
time to peak observed
Measured: -30 minutes before administration until 24 hours after administration
Secondary outcomes (1)
AE/serious AE
Adverse event/serious adverse event
Measured: From screening up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Responsible party
- Sponsor
- Investigators
- Mingxia Wang, PhD, Study director, Medical Ethics Committee of theThe fourth hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841720
- Sponsor's protocol ID
- HSK16149-103
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Drug-drug Interaction Between HSK16149 Capsules and Metformin Hydrochloride Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04841720
- Acronym / sponsor ID
- HSK16149-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Medical University Fourth Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 12 Apr 2021 (actual)
- 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.
This study is a single-center, open, single-arm study, conducted in healthy Chinese populations, and plans to enroll 22 healthy adult subjects (the ratio of either sex is not less than 1/3).
Detailed description
All subjects received the following drugs:
Phase 1-HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8); Phase 2-Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15); Phase 3-Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK16149 | Experimental | Drug: HSK16149HSK16149（D1-D5） |
| Metformin | Experimental | Drug: Metformin Hydrochloride tabletMetformin |
| HSK16149+Metformin | Experimental | Drug: HSK16149+Metformin（phase 3）HSK16149+Metformin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-50 years old (including 18 and 50 years old), healthy male or female;
- Weight: male ≥50 kg, female ≥45kg; body mass index (BMI) in the range of 19-28kg/m2 (including 19 and 28);
- Serum creatinine during the screening period is within the normal range, or creatinine clearance rate (CCr) ≥80mL/min;
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (posterior anterior position), and laboratory examination indicators are normal or abnormal and have no clinical significance;
- Agree to have no birth plan and be able to take reliable contraceptive measures within 3 months after the end of the trial; Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent.
Key exclusion criteria (16 listed)
- Those who are known to have a history of allergies, allergic diseases or allergies to the research preparation and any of its ingredients or related preparations, or those who have a history of pregabalin or gabapentin allergy;
- Those who have special requirements for diet and cannot comply with a unified diet;
- Those who have had angioedema in the past;
- Clinically significant dizziness or vertigo, or a history of inner ear diseases known to cause dizziness or vertigo;
- QTcF>450 milliseconds (msec) found in the screening period inspection;
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 |
|---|---|---|
| HSK16149Also: HSK16149（phase 1）HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8); | Drug | HSK16149 |
| Metformin Hydrochloride tabletAlso: Metformin hydrochloride tablets（phase 2）Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15); | Drug | Metformin |
| HSK16149+Metformin（phase 3）Also: HSK16149 capsules and Metformin hydrochloride tabletsCombined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach. | Drug | HSK16149+Metformin |
Primary outcome
Cmax
Time frame: -30 minutes before administration until 24 hours after administration
Peak concentration
AUC0-t, AUC0-∞
Time frame: -30 minutes before administration until 24 hours after administration
Area under the concentration-time curve
Tmax
Time frame: -30 minutes before administration until 24 hours after administration
time to peak observed
1 secondary outcome
AE/serious AE
Time frame: From screening up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Mingxia Wang, PhD study director
Medical Ethics Committee of theThe fourth hospital of Hebei Medical University
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 HSK16149, Metformin Hydrochloride tablet and HSK16149+Metformin（phase 3） in people with Diabetic Neuropathies and Diabetic Neuropathy Peripheral, run by Haisco Pharmaceutical Group 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Chen, PhD (028-82378557, chenk@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: -30 minutes before administration until 24 hours after administration). The study lists 3 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 12 Apr 2021.