Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bundang CHA Hospital

Criteria

Inclusion Criteria:

• Healthy male subjects aged 20 - 45 years

• BMI (body mass index) between 18.0 and 27.0

• Agreement with written informed consent

Exclusion Criteria:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)

• Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin > 1.5 x UNL)

• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab

• Taking OTC (Over the counter) medicine including oriental medicine within 7 days

• Clinically significant allergic disease

• Subject with known for hypersensitivity reaction to Cilostazol

• Previous whole blood donation within 60 days or component blood donation within 30 days

• Previous participation of other trial within 90 days

• Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)