NCT01723891

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

First QC Date

November 6, 2012

Last Update Submit

November 7, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • AUCt, Cmax

Secondary Outcomes (1)

  • AUCinf, Tmax, t1/2

Study Arms (2)

Surfolase capsule & HT-002-01

ACTIVE COMPARATOR
Drug: Surfolase capsuleDrug: HT-002-01

HT-002-01 & Surfolase capsule

ACTIVE COMPARATOR
Drug: Surfolase capsuleDrug: HT-002-01

Interventions

Surfolase capsuleDRUG
HT-002-01 & Surfolase capsuleSurfolase capsule & HT-002-01
HT-002-01DRUG
HT-002-01 & Surfolase capsuleSurfolase capsule & HT-002-01

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
  • Volunteers without apriority of chronic disease
  • 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
  • Volunteers who comply with the protocol, understand and sign an informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 8, 2012

Study Start

November 1, 2012

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

KR(1)