Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population

Soyoung Lee, Seonghae Yoon, Hyewon Chung, Sang Chun Ji, Seo Hyun Yoon, Kyung-Sang Yu, Joo-Youn Cho, Jae Yong Chung

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.

Original languageEnglish
Pages (from-to)1085-1092
Number of pages8
JournalJournal of Clinical Pharmacology
Volume59
Issue number8
DOIs
StatePublished - 1 Aug 2019

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Ursodeoxycholic Acid
Young Adult
Volunteers
Pharmacokinetics
Population
MicroRNAs
Biliary Liver Cirrhosis
Transferases
Aspartate Aminotransferases
Bile Acids and Salts
Alanine Transaminase
Healthy Volunteers
Reference Values

Keywords

  • G-UDCA
  • T-UDCA
  • UDCA
  • elderly
  • pharmacokinetics

Cite this

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title = "Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population",
abstract = "Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.",
keywords = "G-UDCA, T-UDCA, UDCA, elderly, pharmacokinetics",
author = "Soyoung Lee and Seonghae Yoon and Hyewon Chung and Ji, {Sang Chun} and Yoon, {Seo Hyun} and Kyung-Sang Yu and Joo-Youn Cho and Chung, {Jae Yong}",
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Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population. / Lee, Soyoung; Yoon, Seonghae; Chung, Hyewon; Ji, Sang Chun; Yoon, Seo Hyun; Yu, Kyung-Sang; Cho, Joo-Youn; Chung, Jae Yong.

In: Journal of Clinical Pharmacology, Vol. 59, No. 8, 01.08.2019, p. 1085-1092.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Lee, Soyoung

AU - Yoon, Seonghae

AU - Chung, Hyewon

AU - Ji, Sang Chun

AU - Yoon, Seo Hyun

AU - Yu, Kyung-Sang

AU - Cho, Joo-Youn

AU - Chung, Jae Yong

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N2 - Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.

AB - Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.

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