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Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers

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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

Brief Summary:
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin® Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 1999
Actual Primary Completion Date : September 1999

Arm Intervention/treatment
Experimental: Asasantin® Drug: Asasantin®
Asasantin® extended release (RAD-SP)

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Area under the plasma drug concentration-time curve at steady state (AUCss) [ Time Frame: up to 144 hours after first drug administration ]
  2. Maximum drug plasma concentration at steady state (Cmax,ss) [ Time Frame: up to 144 hours after first drug administration ]
  3. Cmax,ss/AUCss [ Time Frame: up to 144 hours after first drug administration ]
  4. Minimum drug plasma concentration at steady state (Cmin,ss) [ Time Frame: up to 144 hours after first drug administration ]
  5. Time to reach Cmax (tmax) [ Time Frame: up to 144 hours after first drug administration ]
  6. Terminal half-life (t1/2) [ Time Frame: up to 144 hours after first drug administration ]
  7. Mean residence time (MRT) [ Time Frame: up to 144 hours after first drug administration ]
  8. Percent peak trough fluctuation (%PTF) [ Time Frame: up to 144 hours after first drug administration ]

Secondary Outcome Measures :
  1. Platelet adenosine uptake inhibition rate (AUI) [ Time Frame: up to 74 hours after first drug administration ]
  2. Malondialdehyde (MDA) production inhibition rate [ Time Frame: up to 74 hours after first drug administration ]
  3. Thromboxane B2 (TXB2) production inhibition rate [ Time Frame: up to 74 hours after first drug administration ]
  4. Number of subjects with adverse events [ Time Frame: up to 14 days after first drug administration ]
  5. Number of subjects with abnormal changes in laboratory parameters [ Time Frame: up to 14 days after first drug administration ]
  6. Number of subjects with abnormal changes in vital signs [ Time Frame: up to 14 days after first drug administration ]
  7. Number of subjects with abnormal changes in electrocardiogram findings [ Time Frame: up to 14 days after first drug administration ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02273479     History of Changes
Other Study ID Numbers: 9.127
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Aspirin, Dipyridamole Drug Combination
Platelet Aggregation Inhibitors