Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pletaal

• Registration Number: NCT01455558
• Lead Sponsor: Severance Hospital

Brief Summary

This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-20
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Healthy male or female volunteers between the ages of 19 and 55 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
• Female subjects showing positive results on a serum pregnancy test before the study, and those who were of childbearing potential agreed to use one of the following medically accepted methods of contraception during the entire period of the study: abstinence, documented tubal ligation at least 1 year before enrollment in the study, documented placement of an intrauterine device with a proven failure rate of <1% per year, or double barrier methods (a spermicide plus a male condom or female diaphragm).

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Exclusion Criteria

• History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
• Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
• Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
• Use of any substance that could induce CYP3A4 synthesis (eg, St. John's wort, other herbal medications).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cilostazol	Pletaal	-

Primary Outcome Measures

Name	Time	Method
Profile of Pharmacokinetics	0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose for test drug; 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36, 48, 72 hours post-dose for reference drug	Cmax, Area Under Curve

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of