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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01723891
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Surfolase capsule Drug: HT-002-01 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012

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

Primary Outcome Measures :
  1. AUCt, Cmax

Secondary Outcome Measures :
  1. AUCinf, Tmax, t1/2

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01723891

Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Hyundai Pharmaceutical Co., LTD.

Responsible Party: Hyundai Pharmaceutical Co., LTD. Identifier: NCT01723891     History of Changes
Other Study ID Numbers: HT-002-01
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012