ClinicalTrials.gg
CompletedNCT05881811Updated Dec 7, 2023

The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects

A Phase 1 interventional study of HSK16149,probenecid, cimetidine in PHN - Post-Herpetic Neuritis, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female).

02

Conditions studied

  • PHN - Post-Herpetic Neuritis

Browse trials for

03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's enrollment of 47 is close to the median of 48 across 51 interventional studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 118 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily sign the form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
  2. 18 years to 50 years (inclusive), male and female;
  3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. (BMI) : 18-28 kg/m2 (inclusive);
  4. Physical examination, vital sign measurements results were deemed appropriate by the investigator;
  5. Not in use of any drug within 2 weeks prior to screening;
  1. Subjects (including partners) are willing to voluntarily use effective from screening to at least 6 months after the last dose administration.

Exclusion criteria

Exclusion Criteria:

  1. Have an allergic history to the main ingredients and/or any auxiliary materials in the research preparation, allergic diseases or allergies, or allergic history to pregabalin or gabapentin, or allergic history to pregabalin or gabapentin or sulfonamides;
  2. Have special requirements for diet and cannot follow the unified diet;
  3. The abnormal results of 12-lead (ECG), chest X-ray (positive position) and routine laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function) during the screening period have clinical significance and are judged by the researchers to be unsuitable to participate in this experiment;
  4. In the screening period, male >450 milliseconds (msec) and female QTcF>470 milliseconds (msec);
  5. dizziness or vertigo with clinical significance and requiring medical intervention, or history of inner ear diseases known to cause dizziness or vertigo;
  6. Insomnia, anxiety disorder, depression disorder or other mental disorders requiring medical intervention;
  7. Use any caffeinated food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the experimental drug, or disagree with the prohibition of using any caffeinated food or drink during the trial;
  8. Suffering from or having suffered from major diseases of cardiovascular system, respiratory system, digestive system, urinary system, hematology, endocrine system, immunity system, skin system or nervous system, including acute diseases or major surgical operations within 3 months before screening;
  9. Suffering from or having suffered from diseases of gastrointestinal tract, liver, kidney or other known diseases that interfere with drug absorption, distribution, metabolism or excretion;
  10. Blood donation or blood loss of ≥400 mL or more within 3 months before the first administration of the experimental drug;
  11. Any drugs that inhibit or induce liver drug metabolizing enzymes have been used within 28 days before the first administration of experimental drugs (such as barbiturates, carbamazepine, phenytoin, and omeprazole; Inhibitor serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines), or any prescription drugs, over-the-counter drugs, Chinese patent medicines and herbs other than the above drugs were taken orally within 14 days before the administration of the experimental drugs;
  12. have participated in clinical trials of other drugs within 3 months before the first administration of experimental drugs;
  13. Use any within 28 days before the first administration of experimental drugs;
  14. At present, they are or have been drug users, or they are positive in drug abuse screening (screening items include: morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine and cocaine);
  15. Regular drinkers within 3 months before the first administration of the experimental drug, that is, those who drink more than 14 units of alcohol per week (1 unit =10g pure alcohol, or 285mL beer [4.9% Alc./Vol] or 30 mL spirits [40% Alc./Vol] or 100 mL wine [12% Alc./Vol]), or the alcohol breath test is positive;
  16. Smoking more than 5 cigarettes per day (or using a considerable amount of nicotine-containing products) within 3 months before the first administration of experimental drugs, or failing to comply with the smoking ban during the trial;
  17. One or more of surface antigen (HBsAg), virus (HCV) antibody, syphilis antibody or (HIV) antibody are positive during the screening period;
  18. Have any history of malignant tumor in recent 10 years;
  19. pregnant or lactating women;
  20. The estimated (eGFR) during the screening period is or has a history of kidney calculi's disease and kidney disease;
  21. Subjects with poor compliance or other factors that are not suitable for participating in this experiment.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    A1

    Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1\~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2.

    Drug: HSK16149,probenecid, cimetidine

  • Experimental
    A2

    Period 1: HSK16149 single dose on D2, 40mg, fasted;probenecid QID (500mg) on D1\~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;

    Drug: HSK16149,probenecid, cimetidine

  • Experimental
    B1

    Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1\~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2.

    Drug: HSK16149,probenecid, cimetidine

  • Experimental
    B2

    Period 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1\~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;

    Drug: HSK16149,probenecid, cimetidine

Interventions

  • DrugHSK16149,probenecid, cimetidine

    40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1\~D4 200mg cimetidine QID from D1\~D4

06

What researchers measure

Primary outcomes

  1. Cmax

    The maximun plasma concentration of HSK16149

    Time frame: From the start to 72 hours after administration

  2. AUC0-t

    Area under the concentration-time curve from time zero to time of last quantifiable concentration

    Time frame: From the start to 72 hours after administration

  3. AUC0-inf

    Area under the concentration-time curve from time zero extrapolated to infinite time

    Time frame: From the start to 72 hours after administration

Secondary outcomes

  1. Tmax

    Time of maximum concentration

    Time frame: From the start to 72 hours after administration

  2. t1/2

    half life

    Time frame: From the start to 72 hours after administration

  3. Vz

    Volume of distribution associated with the terminal phase

    Time frame: From the start to 72 hours after administration

  4. CL

    Plasma clearance

    Time frame: From the start to 72 hours after administration

  5. Ae

    Cumulative urinary recovery of unchanged drug

    Time frame: From the start to 72 hours after administration

  6. Fe

    Cumulative urinary recovery fraction of unchanged drug

    Time frame: From the start to 72 hours after administration

  7. CLr

    Renal clearance

    Time frame: From the start to 72 hours after administration

07

Study locations

1 site
  • Beijing Jishuitan Hoispital
    Beijing, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2023 to primary completion in Apr 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
May 31, 2023
StartActual
Mar 20, 2023
Primary completionActual
Apr 24, 2023
CompletionActual
Jun 5, 2023
Last update
Dec 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05881811
Responsible party
Sponsor
First posted
May 31, 2023
Start date
Mar 20, 2023
Primary completion
Apr 24, 2023
Completion
Jun 5, 2023
Last update
Dec 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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