Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese 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.
 
ClinicalTrials.gov Identifier: NCT02273479
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE July 1999
Actual Primary Completion Date September 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Area under the plasma drug concentration-time curve at steady state (AUCss) [ Time Frame: up to 144 hours after first drug administration ]
  • Maximum drug plasma concentration at steady state (Cmax,ss) [ Time Frame: up to 144 hours after first drug administration ]
  • Cmax,ss/AUCss [ Time Frame: up to 144 hours after first drug administration ]
  • Minimum drug plasma concentration at steady state (Cmin,ss) [ Time Frame: up to 144 hours after first drug administration ]
  • Time to reach Cmax (tmax) [ Time Frame: up to 144 hours after first drug administration ]
  • Terminal half-life (t1/2) [ Time Frame: up to 144 hours after first drug administration ]
  • Mean residence time (MRT) [ Time Frame: up to 144 hours after first drug administration ]
  • Percent peak trough fluctuation (%PTF) [ Time Frame: up to 144 hours after first drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Platelet adenosine uptake inhibition rate (AUI) [ Time Frame: up to 74 hours after first drug administration ]
  • Malondialdehyde (MDA) production inhibition rate [ Time Frame: up to 74 hours after first drug administration ]
  • Thromboxane B2 (TXB2) production inhibition rate [ Time Frame: up to 74 hours after first drug administration ]
  • Number of subjects with adverse events [ Time Frame: up to 14 days after first drug administration ]
  • Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 14 days after first drug administration ]
  • Number of subjects with abnormal changes in vital signs [ Time Frame: up to 14 days after first drug administration ]
  • Number of subjects with abnormal changes in electrocardiogram findings [ Time Frame: up to 14 days after first drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers
Official Title  ICMJE Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) 200/25 mg Capsules b.i.d. in Randomised, Double-blind, Placebo-controlled Study in Japanese Healthy Male Volunteers
Brief Summary Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Asasantin®
    Asasantin® extended release (RAD-SP)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Asasantin®
    Intervention: Drug: Asasantin®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
32
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male volunteers judged by the investigator as appropriate subjects on the basis of screening test results
  • Age range: ≥ 20 years and ≤ 35 years
  • Body weight between 50 and 80 kg
  • Obesity is within ± 20% of the standard body weight
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • History of drug allergy
  • History of bronchial asthma
  • History of drug abuse and alcohol abuse
  • History of hemorrhagic tendency or hemorrhagic disease
  • Volunteers who have experiences in playing sports such as boxing which may damage the brain
  • Accidents associated with brain concussion and contusion (traffic accident, etc.)
  • Administration of other study drug within 4 months before start of administration of this study drug
  • Collection of whole blood (≥ 400 ml) within 3 months before study drug administration
  • Collection of component blood (≥ 400 ml) within 1 months before study drug administration
  • Intake of some drug or other within 10 days before the study drug administration
  • Excessive physical activities within the last 5 days prior to study drug administration
  • Intake of alcohol within 3 days before study drug administration
  • Volunteers judged by the investigator to be inappropriate as the subjects of study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273479
Other Study ID Numbers  ICMJE 9.127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date October 2014

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