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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Asasantin®

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Asasantin®	Drug: Asasantin®; Asasantin® extended release (RAD-SP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of subjects with abnormal changes in vital signs	up to 14 days after first drug administration
Number of subjects with abnormal changes in electrocardiogram findings	up to 14 days after first drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1999
• Primary Completion (Actual): September 1, 1999
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Platelet Aggregation Inhibitors; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No