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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723891

Enrollment

Registered

2012-11-08

Start date

2012-11-30

Completion date

Unknown

Last updated

2012-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGSurfolase capsule

DRUGHT-002-01

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

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

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

Design outcomes

Primary

Measure	Time frame
AUCt, Cmax	—

Secondary

Measure	Time frame
AUCinf, Tmax, t1/2	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026