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CoughPhase 1NCT03922373

A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

A Phase 1 study testing Group A: Benzonatate 100mg, Group B: Benzonatate 200mg and Group C: Benzonatate 400mg in people with Cough, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cough
What is being tested?
Group A: Benzonatate 100mg, Group B: Benzonatate 200mg and Group C: Benzonatate 400mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Sep 2018to 30 Apr 2019
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

  • 1. You should fully understand the testing content, process and adverse reaction. Freely given informed consent.
  • 2. Male or Female ages 18 through 45 (include 18 and 45).
  • 3. The male subjects weighed more than 50 kg, the female subjects weighed more than 45kg. Body Mass Index(BMI) between 18 and 28, BMI=Weight(kg)/Height2(m2).

Who cannot join

  • 1. Allergy to benzonatate, allergic constitution (Allergic to a variety of medicines and foods).
  • 2. Abnormal physical examination and abnormal vital signs, and have clinical significance.
  • 3. Abnormal results of laboratory studies and have clinical significance. 4. Abnormal electrocardiogram and have clinical significance. 5. The hepatitis B surface antigen(HbsAg), hepatitis C antibody, HIV antibody and antigen, Treponema pallidum antibody（TP-Ab）were positive.
  • 6. Patients with cardiovascular system, urinary system, digestive system, nervous system, respiratory system, mental or immunodeficiency diseases.
  • 7. Dysphagia or with gastrointestinal history influencing drug absorption. 8. Patients with any diseases that increase the risk of bleeding (e.g. acute gastritis, duodenal ulcer, and so on).
  • 9. Patients smoked more than 5 cigarettes a day in the first 3 months of screening 10. Alcohol breath test were positive (blood-alcohol concentration>0.0mg/100ml) , or have history of alcoholism (more than 14 units of alcohol every week, 1 unit is equal to 285ml of beer, 25ml of spririts, or 100ml of wine.
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  • 11. Drug abuse screening were positive by urinalysis, or have a history of substance abuse or taken drugs last 3 years.
  • 12. Subjects (or his fere) have family planning in the next 3 months, or can't take effective contraceptive measures in the next 3 months.
  • 13. Female subjects during lactation, the quantitative of β-HCG exceed the upper limit of normal range.
  • 14. Donate blood or massive blood loss (>450ml) in the first 3 months of screening.
  • 15. Taken any drugs that can inhibit the activity of liver enzyme in the first 28 days of screening, or taken the inhibitor or inducer of CYP3A4, P-gp, Bcrp, such as Itraconazole, Ketoconazole, Dronedarone.
  • 16. Taken any prescription drugs, OTC, vitamin products or Chinese herbal medicine in the first 14 days of screening.
  • 17. Special diets (e.g. pitaya, mango, pomelo) or strenuous exercise in the first 14 days of screening, or other factors to influence drug absorption, distribution, metabolism and excretion.
  • 18. Have attended clinical trial in the first 3 months of screening 19. The patient can't finish the study according to protocol requirements. 20. Acute disease or simultaneous medication between screening stage and the first time taking study drugs.
  • 21. Have consumed any alcoholic or caffeinated food or beverage such as chocolate and coffee in the first 48 hours of taking the study drug.
  • 22. Investigator believes other factors not suitable for testing.

Trial locations and contacts

1 site in 1 country.

Kun Lou contact

0311-67808817

loukun@mail.ecspc.com

China1 site, 1 recruiting

  • Cspc Nbp Pharmaceutical.Co.Ltd

    Shijiazhuang, Hebei, 050000

    Kun Lou, 0311-67808817, loukun@mail.ecspc.com

    Recruiting

Other trials in China

About this study

Official title: The Single-dose and Multiple-dose Pharmacokinetic Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects.

Read the detailed description

Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects. The study was designed to be single-center, open, and parallel, there are 3 groups A, B, C, each group will be enrolled in 12 healthy adult subjects. Single-dose of pharmacokinetics will be carried out in group A and C, single-dose and multiple-dose of pharmacokinetics will be carried out in group B. Subjects in group A and C will be given benzonatate of 100mg and 400mg respectively, Subjects in group B will be given benzonatate of 200mg. Subjects in group A and C will be given benzonatate once after a 10-hour fast in the first day of the trail. Subjects in group B will be given benzonatate once after a 10-hour fast in the first day of the trail, and they will be given benzonatate thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate once after a 10-hour fast. After completing blood collection and safety inspection at the appropriate time points, subjects can leave the test center. The main pharmacokinetic parameters will be calculated, to fully reflect the characteristics of drug absorption, distribution, metabolism and excretion in human body. The main pharmacokinetic parameters include Tmax, Cmax, Css, AUC0-t, AUC0-∞, λz, t1/2, Vd/F, CL/F, and so on.

Conditions
Cough
Being tested
Group A: Benzonatate 100mg, Group B: Benzonatate 200mg, Group C: Benzonatate 400mg
Medical subject headings
Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: Benzonatate 100mgDrug

    Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail

  • Group B: Benzonatate 200mgDrug

    Subjects in group B will be given benzonatate 200mg once after a 10-hour fast in the first day of the trail, and they will be given benzonatate 200mg thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate 200mg once after a 10-hour fast.

  • Group C: Benzonatate 400mgDrug

    Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail

Study groups in NCT03922373
Study groupRoleWhat they receive
BenzonatateExperimentalNot described
Receives: Drug: Group A: Benzonatate 100mg; Drug: Group B: Benzonatate 200mg; Drug: Group C: Benzonatate 400mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tmax

    Time to peak

    Measured: day 1 and day 4

  2. Cmax

    peak plasma concentration

    Measured: day 1 and day 4

  3. t1/2

    elimination half-life time

    Measured: day 1 and day 4

  4. AUC0-t

    Area under the plasma concentration versus time curve from the medication to the last time the concentration can be measured

    Measured: day 1 and day 4

  5. AUC0-∞

    Area under the plasma concentration versus time curve from the medication extrapolate the infinity time

    Measured: day 1 and day 4

  6. CL/F

    elimination ratio

    Measured: day 1 and day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start10 Sep 2018
  3. Primary completion27 Feb 2019
  4. Study completion30 Apr 2019 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03922373
Sponsor's protocol ID
EY20170502
Status last verified
Apr 2019
First submitted
31 Oct 2018
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Group A: Benzonatate 100mg, Group B: Benzonatate 200mg and Group C: Benzonatate 400mg in people with Cough, run by CSPC ZhongQi Pharmaceutical Technology 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 3 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 19 Apr 2019. 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 Kun Lou (0311-67808817, loukun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tmax (time frame: day 1 and day 4). 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?

On the ClinicalTrials.gov record for NCT03922373.

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 19 Apr 2019.

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