Abstract
Ojeok-san is a frequently used herbal medication for the management of osteoarthritic pain. We evaluated the effect of Ojeok-san on the pharmacokinetics of celecoxib at steady-state in healthy individuals. An open-label, fixed-sequence, two-period, two-treatment cross-over study was conducted. In period I, the individuals received celecoxib capsule 200 mg once daily for 4 days. In period II, only Ojeok-san (14.47 g/pack, three times daily) was administered for 4 days, followed by co-administration with celecoxib for 4 days. On the fourth (final) day of administration, Ojeok-san was administered as a single dose. The blood samples for pharmacokinetic evaluation were collected for up to 48 hr after the administration of celecoxib in each study period. Of the 22 enrolled individuals, 20 individuals completed the study. In the presence of Ojeok-san, the systemic exposure of celecoxib was decreased. The geometric mean ratios ([celecoxib + Ojeok-san]/celecoxib) and the 90% confidence intervals for the maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve during dosing interval (AUCτ) of celecoxib at steady-state were 0.725 (0.620–0.848) and 0.885 (0.814–0.962), respectively. The changes in the mean of the Cmax and AUCτ of celecoxib were greater in intermediate metabolizers of cytochrome 2C9 (CYP2C9) than in normal metabolizers. Our results suggested that the Cmax and AUCτ of celecoxib were reduced by Ojeok-san co-administration. This finding may be beneficial to determine the required adjustment of celecoxib dosage when co-administered with Ojeok-san.
| Original language | English |
|---|---|
| Pages (from-to) | 51-57 |
| Number of pages | 7 |
| Journal | Basic and Clinical Pharmacology and Toxicology |
| Volume | 123 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2018 Jul 1 |
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ASJC Scopus subject areas
- Toxicology
- Pharmacology
Cite this
Effects of Ojeok-san on the Pharmacokinetics of Celecoxib at Steady-state in Healthy Volunteers. / Park, Sang In; Park, Ji-Young; Park, Min Ju; Yim, Sung Vin; Kim, Bo Hyung.
In: Basic and Clinical Pharmacology and Toxicology, Vol. 123, No. 1, 01.07.2018, p. 51-57.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Effects of Ojeok-san on the Pharmacokinetics of Celecoxib at Steady-state in Healthy Volunteers
AU - Park, Sang In
AU - Park, Ji-Young
AU - Park, Min Ju
AU - Yim, Sung Vin
AU - Kim, Bo Hyung
PY - 2018/7/1
Y1 - 2018/7/1
N2 - Ojeok-san is a frequently used herbal medication for the management of osteoarthritic pain. We evaluated the effect of Ojeok-san on the pharmacokinetics of celecoxib at steady-state in healthy individuals. An open-label, fixed-sequence, two-period, two-treatment cross-over study was conducted. In period I, the individuals received celecoxib capsule 200 mg once daily for 4 days. In period II, only Ojeok-san (14.47 g/pack, three times daily) was administered for 4 days, followed by co-administration with celecoxib for 4 days. On the fourth (final) day of administration, Ojeok-san was administered as a single dose. The blood samples for pharmacokinetic evaluation were collected for up to 48 hr after the administration of celecoxib in each study period. Of the 22 enrolled individuals, 20 individuals completed the study. In the presence of Ojeok-san, the systemic exposure of celecoxib was decreased. The geometric mean ratios ([celecoxib + Ojeok-san]/celecoxib) and the 90% confidence intervals for the maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve during dosing interval (AUCτ) of celecoxib at steady-state were 0.725 (0.620–0.848) and 0.885 (0.814–0.962), respectively. The changes in the mean of the Cmax and AUCτ of celecoxib were greater in intermediate metabolizers of cytochrome 2C9 (CYP2C9) than in normal metabolizers. Our results suggested that the Cmax and AUCτ of celecoxib were reduced by Ojeok-san co-administration. This finding may be beneficial to determine the required adjustment of celecoxib dosage when co-administered with Ojeok-san.
AB - Ojeok-san is a frequently used herbal medication for the management of osteoarthritic pain. We evaluated the effect of Ojeok-san on the pharmacokinetics of celecoxib at steady-state in healthy individuals. An open-label, fixed-sequence, two-period, two-treatment cross-over study was conducted. In period I, the individuals received celecoxib capsule 200 mg once daily for 4 days. In period II, only Ojeok-san (14.47 g/pack, three times daily) was administered for 4 days, followed by co-administration with celecoxib for 4 days. On the fourth (final) day of administration, Ojeok-san was administered as a single dose. The blood samples for pharmacokinetic evaluation were collected for up to 48 hr after the administration of celecoxib in each study period. Of the 22 enrolled individuals, 20 individuals completed the study. In the presence of Ojeok-san, the systemic exposure of celecoxib was decreased. The geometric mean ratios ([celecoxib + Ojeok-san]/celecoxib) and the 90% confidence intervals for the maximum plasma concentration (Cmax) and the area under the plasma concentration–time curve during dosing interval (AUCτ) of celecoxib at steady-state were 0.725 (0.620–0.848) and 0.885 (0.814–0.962), respectively. The changes in the mean of the Cmax and AUCτ of celecoxib were greater in intermediate metabolizers of cytochrome 2C9 (CYP2C9) than in normal metabolizers. Our results suggested that the Cmax and AUCτ of celecoxib were reduced by Ojeok-san co-administration. This finding may be beneficial to determine the required adjustment of celecoxib dosage when co-administered with Ojeok-san.
UR - http://www.scopus.com/inward/record.url?scp=85048578897&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85048578897&partnerID=8YFLogxK
U2 - 10.1111/bcpt.12971
DO - 10.1111/bcpt.12971
M3 - Article
C2 - 29377603
AN - SCOPUS:85048578897
VL - 123
SP - 51
EP - 57
JO - Basic and Clinical Pharmacology and Toxicology
JF - Basic and Clinical Pharmacology and Toxicology
SN - 1742-7835
IS - 1
ER -