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

NCT02273479 | Completed Phase 1

• 1 other identifier: 9.127
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Area under the plasma drug concentration-time curve at steady state (AUCss)

  up to 144 hours after first drug administration

• Maximum drug plasma concentration at steady state (Cmax,ss)

  up to 144 hours after first drug administration

• Cmax,ss/AUCss

  up to 144 hours after first drug administration

• Minimum drug plasma concentration at steady state (Cmin,ss)

  up to 144 hours after first drug administration

• Time to reach Cmax (tmax)

  up to 144 hours after first drug administration

• Terminal half-life (t1/2)

  up to 144 hours after first drug administration

• Mean residence time (MRT)

  up to 144 hours after first drug administration

• Percent peak trough fluctuation (%PTF)

  up to 144 hours after first drug administration

Secondary Outcomes (7)

• Platelet adenosine uptake inhibition rate (AUI)

  up to 74 hours after first drug administration

• Malondialdehyde (MDA) production inhibition rate

  up to 74 hours after first drug administration

• Thromboxane B2 (TXB2) production inhibition rate

  up to 74 hours after first drug administration

• Number of subjects with adverse events

  up to 14 days after first drug administration

• Number of subjects with abnormal changes in laboratory parameters

  up to 14 days after first drug administration

Study Arms (2)

Asasantin®

EXPERIMENTAL

Drug: Asasantin®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Asasantin® DRUG

Asasantin® extended release (RAD-SP)

Asasantin®

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination

Intervention Hierarchy (Ancestors)

Aspirin; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: July 1, 1999
• Primary Completion: September 1, 1999
• Last Updated: October 24, 2014

Record last verified: 2014-10