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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Surfolase capsule; Drug: HT-002-01

• Registration Number: NCT01723891
• Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Last Update Submitted: 2012-11-07
• Study First Posted: 2012-11-08
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HT-002-01 & Surfolase capsule	HT-002-01	-
Surfolase capsule & HT-002-01	Surfolase capsule	-
Surfolase capsule & HT-002-01	HT-002-01	-
HT-002-01 & Surfolase capsule	Surfolase capsule	-

Primary Outcome Measures

Name	Time	Method
AUCt, Cmax

Secondary Outcome Measures

Name	Time	Method
AUCinf, Tmax, t1/2

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of