Bioequivalence study of cilostazol 20% powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects

Setsuo Hasegawa, Kazunori Saito, Michiko Kainuma, Kazuhiro Matsuki, Yoshinobu Yasuda, Seong Ryul Kim, Naoko Shimofurutani, Eiichi Saito

Research output: Contribution to journalArticle

Abstract

Cilostazol 20% powder is an orally disintegrated formulation that was newly developed for easier swallowing by patients with swallowing disorders that make it difficult for them to take cilostazol tablets with water. The bioequivalence of cilostazol 20% powder 0.5 g ingested with or without water and one cilostazol 100 mg tablet ingested with water was evaluated in 33 healthy adult male subjects in an open-label, randomized, 2-formulation, 2-treatment, 3-period crossover study. The differences (powder without water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder without water and the tablet were respectively log (0.93) and log (1.05), with respective 90% confidence intervals of log (0.87) to log (0.99) and log(O.96) to log(1.14). The differences (powder with water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder with water and the tablet were respectively log(0.87) and log(1.02), with respective 90% confidence intervals of log (0.81) to log (0.92) and log (0.94) to log (1.11). All values were within the range of the judgment criteria of log (0.8) to log (1.25) specified in the guideline for bioequivalence studies. Based on the above results, cilostazol 20% powder 0.5 g, when administered either with or without water, was judged to be bioequivalent to one cilostazol 100 mg tablet. All adverse events observed in all groups were mild in severity and were resolved without treatment. No deaths or other serious adverse events or clinically significant adverse events occurred.

Original languageEnglish
Pages (from-to)81-88
Number of pages8
JournalJapanese Pharmacology and Therapeutics
Volume35
Issue number1
Publication statusPublished - 01-12-2007

Fingerprint

Therapeutic Equivalency
Powders
Tablets
Water
Area Under Curve
Confidence Intervals
cilostazol
Deglutition
Deglutition Disorders
Cross-Over Studies
Guidelines
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Hasegawa, Setsuo ; Saito, Kazunori ; Kainuma, Michiko ; Matsuki, Kazuhiro ; Yasuda, Yoshinobu ; Kim, Seong Ryul ; Shimofurutani, Naoko ; Saito, Eiichi. / Bioequivalence study of cilostazol 20% powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects. In: Japanese Pharmacology and Therapeutics. 2007 ; Vol. 35, No. 1. pp. 81-88.
@article{d77152328f564be09d380d1cd34450e7,
title = "Bioequivalence study of cilostazol 20{\%} powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects",
abstract = "Cilostazol 20{\%} powder is an orally disintegrated formulation that was newly developed for easier swallowing by patients with swallowing disorders that make it difficult for them to take cilostazol tablets with water. The bioequivalence of cilostazol 20{\%} powder 0.5 g ingested with or without water and one cilostazol 100 mg tablet ingested with water was evaluated in 33 healthy adult male subjects in an open-label, randomized, 2-formulation, 2-treatment, 3-period crossover study. The differences (powder without water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder without water and the tablet were respectively log (0.93) and log (1.05), with respective 90{\%} confidence intervals of log (0.87) to log (0.99) and log(O.96) to log(1.14). The differences (powder with water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder with water and the tablet were respectively log(0.87) and log(1.02), with respective 90{\%} confidence intervals of log (0.81) to log (0.92) and log (0.94) to log (1.11). All values were within the range of the judgment criteria of log (0.8) to log (1.25) specified in the guideline for bioequivalence studies. Based on the above results, cilostazol 20{\%} powder 0.5 g, when administered either with or without water, was judged to be bioequivalent to one cilostazol 100 mg tablet. All adverse events observed in all groups were mild in severity and were resolved without treatment. No deaths or other serious adverse events or clinically significant adverse events occurred.",
author = "Setsuo Hasegawa and Kazunori Saito and Michiko Kainuma and Kazuhiro Matsuki and Yoshinobu Yasuda and Kim, {Seong Ryul} and Naoko Shimofurutani and Eiichi Saito",
year = "2007",
month = "12",
day = "1",
language = "English",
volume = "35",
pages = "81--88",
journal = "Japanese Pharmacology and Therapeutics",
issn = "0386-3603",
publisher = "Life Science Publishing Co. Ltd",
number = "1",

}

Hasegawa, S, Saito, K, Kainuma, M, Matsuki, K, Yasuda, Y, Kim, SR, Shimofurutani, N & Saito, E 2007, 'Bioequivalence study of cilostazol 20% powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects', Japanese Pharmacology and Therapeutics, vol. 35, no. 1, pp. 81-88.

Bioequivalence study of cilostazol 20% powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects. / Hasegawa, Setsuo; Saito, Kazunori; Kainuma, Michiko; Matsuki, Kazuhiro; Yasuda, Yoshinobu; Kim, Seong Ryul; Shimofurutani, Naoko; Saito, Eiichi.

In: Japanese Pharmacology and Therapeutics, Vol. 35, No. 1, 01.12.2007, p. 81-88.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Bioequivalence study of cilostazol 20% powder 0.5 g and cilostazol 100 mg tablets in healthy adult male subjects

AU - Hasegawa, Setsuo

AU - Saito, Kazunori

AU - Kainuma, Michiko

AU - Matsuki, Kazuhiro

AU - Yasuda, Yoshinobu

AU - Kim, Seong Ryul

AU - Shimofurutani, Naoko

AU - Saito, Eiichi

PY - 2007/12/1

Y1 - 2007/12/1

N2 - Cilostazol 20% powder is an orally disintegrated formulation that was newly developed for easier swallowing by patients with swallowing disorders that make it difficult for them to take cilostazol tablets with water. The bioequivalence of cilostazol 20% powder 0.5 g ingested with or without water and one cilostazol 100 mg tablet ingested with water was evaluated in 33 healthy adult male subjects in an open-label, randomized, 2-formulation, 2-treatment, 3-period crossover study. The differences (powder without water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder without water and the tablet were respectively log (0.93) and log (1.05), with respective 90% confidence intervals of log (0.87) to log (0.99) and log(O.96) to log(1.14). The differences (powder with water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder with water and the tablet were respectively log(0.87) and log(1.02), with respective 90% confidence intervals of log (0.81) to log (0.92) and log (0.94) to log (1.11). All values were within the range of the judgment criteria of log (0.8) to log (1.25) specified in the guideline for bioequivalence studies. Based on the above results, cilostazol 20% powder 0.5 g, when administered either with or without water, was judged to be bioequivalent to one cilostazol 100 mg tablet. All adverse events observed in all groups were mild in severity and were resolved without treatment. No deaths or other serious adverse events or clinically significant adverse events occurred.

AB - Cilostazol 20% powder is an orally disintegrated formulation that was newly developed for easier swallowing by patients with swallowing disorders that make it difficult for them to take cilostazol tablets with water. The bioequivalence of cilostazol 20% powder 0.5 g ingested with or without water and one cilostazol 100 mg tablet ingested with water was evaluated in 33 healthy adult male subjects in an open-label, randomized, 2-formulation, 2-treatment, 3-period crossover study. The differences (powder without water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder without water and the tablet were respectively log (0.93) and log (1.05), with respective 90% confidence intervals of log (0.87) to log (0.99) and log(O.96) to log(1.14). The differences (powder with water-tablet, point estimates) in the mean log-transformed AUC 60h and C max values between the powder with water and the tablet were respectively log(0.87) and log(1.02), with respective 90% confidence intervals of log (0.81) to log (0.92) and log (0.94) to log (1.11). All values were within the range of the judgment criteria of log (0.8) to log (1.25) specified in the guideline for bioequivalence studies. Based on the above results, cilostazol 20% powder 0.5 g, when administered either with or without water, was judged to be bioequivalent to one cilostazol 100 mg tablet. All adverse events observed in all groups were mild in severity and were resolved without treatment. No deaths or other serious adverse events or clinically significant adverse events occurred.

UR - http://www.scopus.com/inward/record.url?scp=56249147864&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=56249147864&partnerID=8YFLogxK

M3 - Article

VL - 35

SP - 81

EP - 88

JO - Japanese Pharmacology and Therapeutics

JF - Japanese Pharmacology and Therapeutics

SN - 0386-3603

IS - 1

ER -