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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Surfolase capsule; Drug: HT-002-01

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
AUCt, Cmax

Secondary Outcome Measures

Outcome Measure
AUCinf, Tmax, t1/2

Collaborators and Investigators

• Sponsor: Hyundai Pharmaceutical Co., LTD.

Study record dates

Study Major Dates

• Study Start: November 1, 2012

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 8, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: HT-002-01