CClinicalTrials.gg
CompletedNCT01723891Updated Nov 8, 2012

Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers

A Phase 1 interventional study of Surfolase capsule and HT-002-01 in Healthy, sponsored by Hyundai Pharmaceutical Co., LTD.. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-08.

Sponsored by Hyundai Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study summary

Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Hyundai Pharmaceutical Co., LTD. is the lead sponsor of 11 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
  2. Volunteers without apriority of chronic disease
  3. Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
  4. Volunteers who comply with the protocol, understand and sign an informed consent

Exclusion criteria

Exclusion Criteria:

  1. Sensitive response to acebrophylline and xanthine
  2. Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
  3. Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
  4. Known history of gastrointestinal disease which affects the absorption of medicine.
  5. Excluded by screening tests
  6. Upper limit of AST, ALT>1.25 times Upper limit of total bilirubin>1.5 times
  7. Estimated GFR\<80mL/min/1.73m2)
  8. systolic blood pressure \< 90 or > 150, diastolic blood pressure \<50 or >100
  9. Known history of drug abuse
  10. caffeine>5cups/day, alcohol>210g/week, 10 more cigarettes/day
  11. Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
  12. Participation in any clinical investigation within 60 days prior to study start
  13. Donation of blood within 60 days, donation of component blood within 30days
  14. Judged by the investigators to be undesirable as subjects
05

Study design

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

Study arms

  • Active comparator
    Surfolase capsule & HT-002-01

    Drug: Surfolase capsule · Drug: HT-002-01

  • Active comparator
    HT-002-01 & Surfolase capsule

    Drug: Surfolase capsule · Drug: HT-002-01

Interventions

  • DrugSurfolase capsule
  • DrugHT-002-01
06

What researchers measure

Primary outcomes

  1. AUCt, Cmax

Secondary outcomes

  1. AUCinf, Tmax, t1/2

07

Study locations

1 site
  • Yonsei University Health System, Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01723891
Lead sponsor
Hyundai Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Nov 8, 2012
Start date
Nov 2012
Last update
Nov 8, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion