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CompletedNCT02273479Updated Oct 24, 2014

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

A Phase 1 interventional study of Asasantin® and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-24.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Asasantin®

    Drug: Asasantin®

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAsasantin®

    Asasantin® extended release (RAD-SP)

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02273479
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Jul 1999
Primary completion
Sep 1999
Last update
Oct 24, 2014
View the source record on ClinicalTrials.gov ↗

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