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Healthy VolunteersPhase 1NCT02373891

Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers

A Phase 1 study testing Surfolase CR in people with Healthy Volunteers, run by Hyundai Pharmaceutical Co., LTD..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally administered as a salt composed of an acid-base as a compound that was synthesized by and chloride (salifying) the ambroxol to 7-theophylline. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Surfolase CR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
Apr 2014to Jul 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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects between the ages of 20 and 55 years, BMI >18.5, <25, inclusive
  • Body mass index(kg/m2) = weight(kg)/(height(m)2)
  • Subject who don't have congenital or chronic diseases and have no abnormal medical examination results.
  • Subject is healthy (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
  • Hematology tests: WBC with differential count, RBC, Hemoglobin, Hematocrit, Platelet, PT(INR)/aPTT
  • Blood chemistry tests: Calcium, Inorganic Phosphate, Fasting Glucose, BUN, Creatinine, Cholesterol, Total Protein, Albumin, Total Bilirubin, Alkaline phosphatase, AST, ALT, r-GT, LDH, TG, K, Na, Cl, uric acid, CPK
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  • Immune serum tests: HBsAg, anti-HCV Ab, anti-HIV Ag/Ab, β-hCG
  • Urinalysis: Specific Gravity, pH, Protein, Glucose, Ketone, RBC, Urobilinogen, Bilirubin, Nitrite, WBC, Color, Turbidity, Sediment, Microscopy
  • Urine drug screening tests: Amphetamine, Barbiturate, Morphine, Benzodiazepine, Cocaine 4) If you are a woman, you must be a negative pregnancy test at screening.
  • Postmenopausal (no period for at least two years)
  • Surgical sterilization (Hysterectomy or bilateral oophorectomy, tubal ligation)
  • Before the screening, interfile male partner and this man is the sole partner of that person
  • Before Investigational product first dose administered at least 14 days before the start appropriate contraception until at least 28 days.
  • 5) If you are a male and sexually active women of childbearing age, during the trial period contraception (condoms, etc.) and clinical trial duration, and IND maintaining adequate contraception up to 28 days after the last dose, and one party must agree that you will not donate sperm 6) Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study

Who cannot join

  • Subject with known for hypersensitivity reaction to acebrophylline, xanthine and food.
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
  • Subject with known for history of gastrointestinal disease or gastrointestinal surgery which affect on the absorption drug
  • Subjects with any of the following condition in screening (blood pressure, 12-lead ECG, blood, urinalysis, etc.)
  • Subject with any of the following conditions in laboratory test
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  • AST or ALT > Upper normal limit × 1.25
  • Total bilirubin > Upper normal limit × 1.5
  • If the estimated GFR < 80mL/min/1.73m2 using MDRD formula.
  • ※ MDRD equation (mL/min/1.73m2)
  • : GFR = 175 x Scr-1.154 x age-0.203
  • Systolic blood pressure <=90mmHg or diastolic blood pressure >=150mmHg or a person showing the corresponding figures <=50mmHg or >=100mmHg in vital signs.
  • Who has history of drug abuse (especially hypnotic, central acting analgesics, psychotropic drugs, such as opiates or central nervous system acting drug) or shows positive reactions to drug of abuse in urine drug screening tests.
  • Excessive caffeine and alcohol intake, smoking person(caffeine: > 5cups/day, alcohol: >210g/week, tobacco: > 10 cagarettes/day)
  • Person cannot be non-smoking, non-alcohol during the hospital stay.
  • Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
  • Participation in any clinical investigation within 60days prior to study medication dosing
  • Subjects with whole blood donation within 60days, component blood donation within 30days
  • Women who are pregnant or breast-feeding
  • Person who cannot eat, including high-fat diet (more than 900kcal, containing more that 35% fat) that served during the trial period
  • Person can not prohibit the consumption of grapefruit-containing food during the trial period.
  • Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

About this study

Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally administered as a salt composed of an acid-base as a compound that was synthesized by and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state is allowed to recuperate or extended.

It was developed to improve compliance improve pharmaceutically Acebrophylline that intake twice daily 100mg to Surfolase CR that intake once daily 200mg

Being tested
Surfolase CR

What participants receive

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

  • Surfolase CRDrug

    T1: Surfolase CR (Acebrophylline 200mg) administration after fat intake Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00

  • Surfolase CRDrug

    T0: Surfolase CR(Acebrophylline 200mg) fasting administration Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00

Study groups in NCT02373891
Study groupRoleWhat they receive
T1ExperimentalNot described
Receives: Drug: Surfolase CR
T0ExperimentalNot described
Receives: Drug: Surfolase CR

What is being measured

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

  1. Ambroxol AUClast, Cmax

    Measured: Fasting medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36 h (17 times), Fat meal medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36h

  2. Ambroxol AUCinf, Tmax, t1/2

    Measured: Fasting medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36 h (17 times), Fat meal medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36h

Timeline

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

  1. First posted27 Feb 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02373891
Sponsor's protocol ID
HT-002-04
Status last verified
Feb 2015
First submitted
11 Feb 2015
Last updated
27 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Surfolase CR in people with Healthy Volunteers, run by Hyundai Pharmaceutical Co., LTD..

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 14 inclusion and 22 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Ambroxol AUClast, Cmax (time frame: Fasting medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36 h (17 times), Fat meal medication: 0 h (before intake), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 24, 36h). The study lists 2 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 NCT02373891.

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 27 Feb 2015.

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