Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01548157
First received: February 27, 2012
Last updated: June 3, 2013
Last verified: April 2013

February 27, 2012
June 3, 2013
March 2012
March 2012   (final data collection date for primary outcome measure)
Area Under Curve(AUC) last [ Time Frame: 0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01548157 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule
A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: HCP1007 / omarco and crestor
HCP1007 / Rosuvastatin plus Omega-3
  • Experimental: HCP1007
    HCP1007
    Intervention: Drug: HCP1007 / omarco and crestor
  • Active Comparator: omarco and crestor
    Rosuvastatin plus Omega-3
    Intervention: Drug: HCP1007 / omarco and crestor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers, age between 20 and 45
  • Informed of the investigational nature of this study and voluntarily agree to participate in this study
  • BMI of >20kg/m2 and <26kg/m2 subject

Exclusion Criteria:

  • Use of any prescription medication within 14 days prior to Day 1
  • Use of any medication within 7 days prior to Day 1
  • Participation in another clinical study within 60 days prior to start of study drug administration
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01548157
HM-ROMA-101
Yes
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: kyun seop Bae, MD, Ph.D Asan Medical Center
Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP