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Completed

NCT Number: NCT01723891

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.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System, Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Surfolase capsule

Drug

HT-002-01

Drug

Primary outcomes

  1. AUCt, Cmax

Secondary outcomes

  1. AUCinf, Tmax, t1/2

Sponsors and collaborators

Lead sponsor

Hyundai Pharmaceutical Co., LTD.

Industry

Registry information

Important dates

Study start
2012
First posted
Nov 8, 2012
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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