| Title |
Pharmacokinetic comparison of sustained- and immediate-release formulations of cilostazol after multiple oral doses in fed healthy male Korean volunteers
|
|---|---|
| Published in |
Drug Design, Development and Therapy, July 2015
|
| DOI | 10.2147/dddt.s86845 |
| Pubmed ID | |
| Authors |
Yo Han Kim, Jong-Lyul Ghim, Jin Ah Jung, Sang-Heon Cho, Sangmin Choe, Hee Youn Choi, Kyun-Seop Bae, Hyeong-Seok Lim |
| Abstract |
A new extended-release form of cilostazol has recently been developed. This study was conducted to compare the pharmacokinetic characteristics of sustained-release (SR) and immediate-release (IR) formulations of cilostazol after multiple oral doses in healthy male Korean volunteers. This was an open-label, randomized, multiple-dose, crossover study conducted in 30 healthy Korean subjects. In each treatment period, subjects received oral doses of 200 mg SR formulation every 24 hours or 100 mg IR formulation every 12 hours for 5 consecutive days in a fed state, with a washout period of 9 days. The plasma concentrations of cilostazol and its metabolites were determined using a validated liquid chromatography-tandem mass spectrometry method. The area under the plasma concentration-time curve within a dosing interval (AUC T ), the measured peak plasma concentration at steady state (C max,ss), and the time to reach C max,ss (t max,ss) were analyzed using a noncompartmental method. A total of 24 healthy male subjects completed the study. The mean (standard deviation [SD]) AUC T (96-120 hours) values for SR and IR were 27,378.0 (10,301.6) ng·h/mL and 27,860.3 (7,152.3) ng·h/mL, respectively. The mean (SD) C max,ss values were 2,741.4 (836.0) ng/mL and 2,051.0 (433.2) ng/mL, respectively. The median t max,ss values were 8.0 hours and 4.0 hours, respectively. The geometric mean ratios (90% confidence intervals) of the SR to IR formulations were 0.937 (0.863-1.017), 0.960 (0.883-1.043), and 0.935 (0.859-1.017) for AUC T and 0.644 (0.590-0.703), 0.586 (0.536-0.642), and 0.636 (0.577-0.702) for dose-normalized C max,ss of cilostazol, OPC-13015 (3,4-dehydro-cilostazol), and OPC-13213 (4'-trans-hydroxyl-cilostazol), respectively. All formulations were well tolerated. At steady state, the AUC T of cilostazol SR 200 mg is comparable to that of cilostazol IR 100 mg twice a day in healthy male Korean subjects. Both formulations are well tolerated. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| India | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Scientists | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 25 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 25 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Lecturer | 4 | 16% |
| Student > Ph. D. Student | 3 | 12% |
| Student > Master | 3 | 12% |
| Student > Doctoral Student | 2 | 8% |
| Professor | 2 | 8% |
| Other | 5 | 20% |
| Unknown | 6 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Nursing and Health Professions | 4 | 16% |
| Biochemistry, Genetics and Molecular Biology | 3 | 12% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 12% |
| Medicine and Dentistry | 3 | 12% |
| Engineering | 2 | 8% |
| Other | 3 | 12% |
| Unknown | 7 | 28% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 12 July 2015.
All research outputs
#20,656,820
of 25,374,917 outputs
Outputs from Drug Design, Development and Therapy
#1,437
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Outputs of similar age
#202,786
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Outputs of similar age from Drug Design, Development and Therapy
#108
of 157 outputs
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