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

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.

Timeline

Start

2009-02

Primary completion

2009-08

Completion

2009-09

Outcome

Mixed primary results

paper In part 1, all the primary pharmacokinetic parameters satisfied the criterion for assumed bioequivalence PMID 22129569 ↗

paper In part 3, only the C(ssmax) of clilostazol in the reference formulation did not satisfy the criterion for assumed bioequivalence PMID 22129569 ↗

Publications

• Lee D, Lim LA, Jang SB, Lee YJ, Chung JY, Choi JR, Kim K, Park JW, Yoon H, Lee J, Park MS, Park K. Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study. Clin Ther. 2011 Dec;33(12):2038-53. doi: 10.1016/j.clinthera.2011.10.024. Epub 2011 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cilostazol	Small molecule	100 mg	Oral
Subject	Cilostazol	Small molecule	200 mg	Oral

Indications

No indication recorded.