Pharmacokinetic profiles of hydrochlorothiazide alone and in combination with benazepril or valsartan in healthy Chinese volunteers: Evaluation of the potential interaction

International Journal of Clinical Pharmacology and Therapeutics

Volumn 49, Issue 12, 2011, Pages 756-764

  Jiang, J ^a   Tian, L ^a   Huang, Y ^a   Xie, S ^a   Xu, L ^a   Liu, H ^a   Li, Y ^a  

^a FUWAI HOSPITAL   (China)

Author keywords

Benazepril; Chinese; Hydrochlorothiazide; Pharmacokinetics; Phase I clinical trial; Valsartan

Indexed keywords

BENAZEPRIL; BENAZEPRIL PLUS HYDROCHLOROTHIAZIDE; CHLORINE; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS VALSARTAN; POTASSIUM; SODIUM; URIC ACID;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHINESE; COMBINATION CHEMOTHERAPY; COMPARATIVE STUDY; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG HALF LIFE; DRUG INHIBITION; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MORNING DOSAGE; NAUSEA; NORMAL HUMAN; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); POTASSIUM BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SINGLE DRUG DOSE; SODIUM BLOOD LEVEL; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; URIC ACID BLOOD LEVEL; VOMITING;

ADOLESCENT; ADULT; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; BENZAZEPINES; CROSS-OVER STUDIES; DIURETICS; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; HUMANS; HYDROCHLOROTHIAZIDE; MALE; MIDDLE AGED; TETRAZOLES; VALINE;

EID: 82655189977     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201583     Document Type: Article

References (30)

1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ, Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003; 42: 1206-1252. doi:10.1161/01.HYP. 0000107251.49515.c2 PubMed (Pubitemid 37553153)
2. European Society of Hypertension-European Society of Cardiology Guidelines Committee. 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens. 2003; 21: 1011-1053. doi:10.1097/00004872-200306000-00001 PubMed
3. Japanese society of hypertension. Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2004). Hypertens Res. 2006; 29 (Suppl): S1-S106.
4. Oigman W, Spritzer N, Introcaso L, Santello JL. Evaluation of efficacy of the enalapril-hydrochlorothiazide combination by ambulatory blood pressure monitoring in essential hypertensive patients. Arq Bras Cardiol. 1993; 60: 123-127. PubMed (Pubitemid 23138330)
5. Chrysant SG, Fagan T, Glazer R, Kriegman A. Effects of benazepril and hydrochlorothiazide, given alone and in low- and high-dose combinations, on blood pressure in patients with hypertension. Arch Fam Med. 1996; 5: 17-24, discussion 25. doi:10.1001/archfami.5.1.17 PubMed
6. Lenz T, Schulte KL, Wagner B, Lilienthal J, Gotzen R. Quinapril, hydrochlorothiazide, and combination in patients with moderate to severe hypertension. Eur Heart J. 1994; 15: 940-946. PubMed (Pubitemid 24223955)
7. Weinberger MH. Angiotensin converting enzyme inhibitors enhance the antihypertensive efficacy of diuretics and blunt or prevent adverse metabolic effects. J Cardiovasc Pharmacol. 1989; 13 (Suppl 3): S1-S4. doi:10.1097/ 00005344-198900133-00002 PubMed (Pubitemid 19172477)
8. Lacourciere Y, Hebet D, Assouline L et al. Effective blood pressure control with valsartan/HCTZ combination therapy in patients with moderate to severe systolic hypertension: The VALOR trial. Am J Hypertens. 2004; 17: 115A. Poster P-225.
9. Mallion JM, Carretta R, Trenkwalder P, Martinez JF, Tykarski A, Teitelbaum I, Oddou P, Fagan T; Co-Diovan Study Group. Valsartan/ hydrochlorothiazide is effective in hypertensive patients inadequately controlled by valsartan monotherapy. Blood Press. 2003; 12 (Suppl 1): 36-43. doi:10.1080/08038020310000122 PubMed (Pubitemid 36681971)
10. Beermann B, Groschinsky-Grind M, Lindstrom B. Bioavailability of two hydrochlorothiazide preparations. Eur J Clin Pharmacol. 1977; 11: 203-205. PubMed doi:10.1007/BF00606411
11. Swaisland AJ. The pharmacokinetics of co-administered lisinopril and hydrochlorothiazide. J Hum Hypertens. 1991; 5 (Suppl 2): 69-71. PubMed
12. Breithaupt-Grögler K, Ungethüm W, Meurer-Witt B, Belz GG. Pharmacokinetic and dynamic interactions of the angiotensin-converting enzyme inhibitor imidapril with hydrochlorothiazide, bisoprolol and nilvadipine. Eur J Clin Pharmacol. 2001; 57: 275-284. doi:10.1007/s002280100323 PubMed (Pubitemid 32703933)
13. O'Grady P, Yee KF, Lins R, Mangold B. Fosinopril/hydrochlorothiazide: single dose and steady-state pharmacokinetics and pharmacodynamics. Br J Clin Pharmacol. 1999; 48: 375-381. doi:10.1046/j.1365-2125.1999.00013.x PubMed (Pubitemid 29417721)
14. Niopas I, Daftsios AC, Nikolaidis N. Evaluation of the bioequivalence of two tablet formulations of enalapril/hydrochlorothiazide after single oral administration to healthy volunteers. Arzneimittelforschung. 2004; 54: 160-165. PubMed (Pubitemid 38392288)
15. Koytchev R, Ozalp Y, Erenmemisoglu A, van der Meer MJ, Alpan RS. Combination of losartan and hydrochlorothiazide: in vivo bioequivalence. Arzneimittelforschung. 2004; 54 (9A): 611-617. PubMed (Pubitemid 39278904)
16. Bhad P, Ayalasomayajula S, Karan R et al. Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension [Published online before print September 17, 2010]. J Clin Pharmaol. [abstract] 2010.
17. Young CL, Dias VC, Stangier J. Multiple-dose pharmacokinetics of telmisartan and of hydrochlorothiazide following concurrent administration in healthy subjects. J Clin Pharmacol. 2000; 40: 1323-1330. PubMed
18. Kreutz R, Bolbrinker J, Huber M. Pharmacokinetics of olmesartan medoxomil plus hydrochlorothiazide combination in healthy subjects. Clin Drug Investig. 2006; 26: 29-34. doi:10.2165/00044011-200626010-00004 PubMed (Pubitemid 43098406)
19. Tutunji LF, Tutunji MF, Alzoubi MI, Khabbas MH, Arida AI. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma using HPLC coupled with tandem mass spectrometry: Application to bioequivalence studies. J Pharm Biomed Anal. 2010; 51: 985-990. doi:10.1016/j.jpba.2009.10.023 PubMed
20. World Medical Association (WMA). Declaration of Helsinki. Presented at the 52nd WMA General Assembly; October 7, 2000; Edinburgh, Scotland.
21. European Agency for the Evaluation of Medicinal Products. International Conference on Harmonisation-World Health Organization. Guideline for Good Clinical Practoce [EMEA Web Site] ICH Topic E6, Geneva, Switzerland: WHO;2002. Available at: http://www.emea.eu.int. Accessed April 13, 2006.
22. Jordö L, Johnsson G, Lundborg P, Persson BA, Regärdh CG, Rönn O. Bioavailability and disposition of metoprolol and hydrochlorothiazide combined in one tablet and of separate doses of hydrochlorothiazide. Br J Clin Pharmacol. 1979; 7: 563-567. PubMed
23. Beermann B, Groschinsky-Grind M. Gastrointestinal absorption of hydrochlorothiazide enhanced by concomitant intake of food. Eur J Clin Pharmacol. 1978; 13: 125-128. doi:10.1007/BF00609756 PubMed (Pubitemid 8346372)
24. Beermann B, Groschinsky-Grind M, Rosén A. Absorption, metabolism, and excretion of hydrochlorothiazide. Clin Pharmacol Ther. 1976; 19: 531-537. PubMed
25. Roux A, Le Liboux A, Delhotal B, Gaillot J, Flouvat B. Pharmacokinetics in man of acebutolol and hydrochlorothiazide as single agents and in combination. Eur J Clin Pharmacol. 1983; 24: 801-806. doi:10.1007/BF00607091 PubMed (Pubitemid 13064474)
26. Upton RA, Williams RL, Lin ET, Gee WL, Blume CD, Benet LZ. Absence of a significant pharmacokinetic interaction between hydrochlorothiazide and triamterene when coadministered. J Pharmacokinet Biopharm. 1984; 12: 575-586. doi:10.1007/BF01059553 PubMed (Pubitemid 15106933)
27. Shoaf SE, Bramer SL, Bricmont P, Zimmer CA. Pharmacokinetic and pharmacodynamic interaction between tolvaptan, a non-peptide AVP antagonist, and furosemide or hydrochlorothiazide. J Cardiovasc Pharmacol. 2007; 50: 213-222. doi:10.1097/FJC.0b013e318074f934 PubMed (Pubitemid 47267748)
28. Vaidyanathan S, Valencia J, Kemp C, Zhao C, Yeh CM, Bizot MN, Denouel J, Dieterich HA, Dole WP. Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers. Int J Clin Pract. 2006; 60: 1343-1356. doi:10.1111/j.1742-1241.2006.01164.x PubMed (Pubitemid 44560330)
29. Li H, Wang YW, Jiang Y, Tang Y, Wang J, Zhao L, Gu J. A liquid chromatography/tandem mass spectrometry method for the simultaneous quantification of valsartan and hydrochlorothiazide in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2007; 852: 436-442. doi:10.1016/j.jchromb.2007.02.014 PubMed (Pubitemid 46830149)
30. Yan TT, Li H, Deng LL, Guo Y, Yu W, Fawcett JP, Zhang D, Cui Y, Gu J. Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma. J Pharm Biomed Anal. 2008; 48: 1225-1229. doi:10.1016/j.jpba.2008.08.021 PubMed