NCT02273479

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

Completed Phase 1 Last updated 23 October 2014

What this trial tests

Phase 1 trial testing Asasantin® in Healthy in 32 participants. Completed.

Timeline

1 July 1999

Primary endpoint
1 September 1999

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	1 July 1999
Primary completion	1 September 1999

Drugs / interventions tested

• Asasantin® — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 20 to 35, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.