دورية أكاديمية
Pharmacokinetic Comparison of a Fixed-Dose Combination of Candesartan Cilexetil/Amlodipine/Atorvastatin Versus Co-administration of Individual Formulations in Healthy Participants.
| العنوان: | Pharmacokinetic Comparison of a Fixed-Dose Combination of Candesartan Cilexetil/Amlodipine/Atorvastatin Versus Co-administration of Individual Formulations in Healthy Participants. |
|---|---|
| المؤلفون: | Kim JH; Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.; Department of Medical Science, Chungnam National University College of Medicine, Daejeon, Republic of Korea., Song JH; Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.; Department of Medical Science, Chungnam National University College of Medicine, Daejeon, Republic of Korea., Kim M; Pharmaceutical Research and Technology Development Center, Chong Kun Dang Pharmaceutical Corporation, Yongin, Gyeonggi, Republic of Korea., Hong JH; Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.; Department of Pharmacology, Chungnam National University College of Medicine, Daejeon, Republic of Korea., Sunwoo J; Clinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea. swj4991@cnuh.co.kr., Jung JG; Department of Family Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea. jjg72@hanmail.net.; Department of Family Medicine, Chungnam National University College of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea. jjg72@hanmail.net. |
| المصدر: | Advances in therapy [Adv Ther] 2024 Jul; Vol. 41 (7), pp. 2808-2825. Date of Electronic Publication: 2024 May 21. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Comparative Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Health Communications Inc Country of Publication: United States NLM ID: 8611864 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1865-8652 (Electronic) Linking ISSN: 0741238X NLM ISO Abbreviation: Adv Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York : Springer Healthcare Communications, 2008- : Health Communications Inc. Original Publication: Metuchen, N.J. : Health Communications Inc., c1984- |
| مواضيع طبية MeSH: | Biphenyl Compounds*/pharmacokinetics , Biphenyl Compounds*/administration & dosage , Amlodipine*/pharmacokinetics , Amlodipine*/administration & dosage , Benzimidazoles*/pharmacokinetics , Benzimidazoles*/administration & dosage , Tetrazoles*/pharmacokinetics , Tetrazoles*/administration & dosage , Cross-Over Studies* , Drug Combinations* , Atorvastatin*/pharmacokinetics , Atorvastatin*/administration & dosage, Humans ; Male ; Adult ; Female ; Young Adult ; Area Under Curve ; Middle Aged ; Angiotensin II Type 1 Receptor Blockers/pharmacokinetics ; Angiotensin II Type 1 Receptor Blockers/administration & dosage ; Calcium Channel Blockers/pharmacokinetics ; Calcium Channel Blockers/administration & dosage ; Therapeutic Equivalency ; Antihypertensive Agents/pharmacokinetics ; Antihypertensive Agents/administration & dosage ; Heptanoic Acids/pharmacokinetics ; Heptanoic Acids/administration & dosage ; Healthy Volunteers |
| مستخلص: | Introduction: Fixed-dose combinations (FDCs) of angiotensin II receptor blockers, calcium channel blockers, and statins are conventional therapeutic interventions prescribed for cardiovascular diseases. This study aimed at drawing a comparison between the pharmacokinetics and safety of an FDC and the corresponding individual formulations in healthy subjects. Methods: A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover study was conducted with a cohort of healthy volunteers. A 14-day washout period was maintained between each of the three periods. In this study, candesartan cilexetil, amlodipine, and atorvastatin was administered orally as FDCs of 16/10/40 mg in study 1 and 16/5/20 mg in study 2. The maximum plasma concentration (C Results: The GMRs (90% CIs) for the AUC Conclusion: The C Trial Registration: ClinicalTrials.gov identifier, study 1: NCT04478097; study 2: NCT04627207. (© 2024. The Author(s).) |
| References: | Clin Pharmacokinet. 2002;41(1):7-17. (PMID: 11825094) Pharmacoepidemiol Drug Saf. 2015 Jun;24(6):637-46. (PMID: 25858336) Br J Gen Pract. 2012 Mar;62(596):163-4. (PMID: 22429432) Hypertension. 1995 Jan;25(1):14-21. (PMID: 7843746) Pharm Res. 2008 Jan;25(1):237-41. (PMID: 17891552) Clin Pharmacokinet. 1992 Jan;22(1):22-31. (PMID: 1532771) Circ Cardiovasc Qual Outcomes. 2009 Mar;2(2):65-72. (PMID: 20031817) Circulation. 2017 Sep 19;136(12):1087-1098. (PMID: 28687710) Blood Press Suppl. 2001;(3):5-10. (PMID: 11683476) BMJ. 2021 Jul 14;374:n1537. (PMID: 34261627) Am J Hypertens. 1999 Dec;12(12 Pt 1-2):1181-7. (PMID: 10619580) Circulation. 2019 Jun 18;139(25):e1082-e1143. (PMID: 30586774) BMC Res Notes. 2014 Jun 05;7:340. (PMID: 24897943) Drugs. 2007;67 Suppl 1:63-9. (PMID: 17910522) BMJ. 2009 Dec 22;339:b4904. (PMID: 20028777) Lancet. 2012 Jul 7;380(9836):37-43. (PMID: 22579043) Int J Clin Pharmacol Ther. 2005 Oct;43(10):485-98. (PMID: 16240706) Drug Des Devel Ther. 2018 Aug 10;12:2475-2483. (PMID: 30127595) Kidney Int Suppl. 1996 Jun;55:S24-9. (PMID: 8743506) Clin Pharmacol Drug Dev. 2020 Apr;9(3):386-394. (PMID: 31373174) J Hypertens. 2023 Dec 1;41(12):1874-2071. (PMID: 37345492) Drugs Aging. 2014 May;31(5):379-86. (PMID: 24687310) Curr Med Chem. 2010;17(6):571-84. (PMID: 20015034) Transl Med UniSa. 2016 Jan 31;13:59-64. (PMID: 27042434) Drug Dev Ind Pharm. 2013 Sep;39(9):1296-9. (PMID: 23030309) Transl Clin Pharmacol. 2017 Dec;25(4):190-195. (PMID: 32095474) BMJ. 2012 Oct 04;345:e6341. (PMID: 23036829) Clin Pharmacokinet. 2003;42(13):1141-60. (PMID: 14531725) J Am Geriatr Soc. 2017 Apr;65(4):747-753. (PMID: 27991653) Arch Intern Med. 2005 May 23;165(10):1147-52. (PMID: 15911728) Clin Pharmacol Ther. 1999 Aug;66(2):118-27. (PMID: 10460065) N Engl J Med. 2017 Aug 24;377(8):745-755. (PMID: 28834469) Acta Clin Belg. 2016 Jun;71(3):158-66. (PMID: 27105401) Clin Pharmacol Drug Dev. 2021 Feb;10(2):190-197. (PMID: 32388918) J Comp Eff Res. 2018 Jul;7(7):651-660. (PMID: 29888950) Korean J Intern Med. 2021 Jan;36(1):124-134. (PMID: 32088938) Clin Pharmacol Ther. 1998 Jul;64(1):58-65. (PMID: 9695720) Drug Des Devel Ther. 2019 May 13;13:1623-1632. (PMID: 31190741) J Hypertens. 2023 Sep 1;41(9):1466-1473. (PMID: 37432906) Pharmacoepidemiol Drug Saf. 2017 Feb;26(2):192-200. (PMID: 27935150) Drug Des Devel Ther. 2020 May 20;14:1953-1961. (PMID: 32546962) JAMA Cardiol. 2017 May 1;2(5):581-582. (PMID: 28199457) Fam Pract. 2007 Feb;24(1):14-9. (PMID: 17164234) N Engl J Med. 2015 Nov 26;373(22):2103-16. (PMID: 26551272) |
| فهرسة مساهمة: | Keywords: Amlodipine; Atorvastatin; Candesartan cilexetil; Fixed-dose combination; Pharmacokinetics |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04478097; NCT04627207 |
| المشرفين على المادة: | 0 (Biphenyl Compounds) 1J444QC288 (Amlodipine) 0 (Benzimidazoles) 0 (Tetrazoles) 0 (Drug Combinations) A0JWA85V8F (Atorvastatin) R85M2X0D68 (candesartan cilexetil) 0 (Angiotensin II Type 1 Receptor Blockers) 0 (Calcium Channel Blockers) 0 (Antihypertensive Agents) 0 (Heptanoic Acids) |
| تواريخ الأحداث: | Date Created: 20240521 Date Completed: 20240628 Latest Revision: 20240701 |
| رمز التحديث: | 20240701 |
| مُعرف محوري في PubMed: | PMC11213815 |
| DOI: | 10.1007/s12325-024-02869-y |
| PMID: | 38771476 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1865-8652 |
|---|---|
| DOI: | 10.1007/s12325-024-02869-y |