Combination of Losartan and Hydrochlorothiazide: In vivo Bioequivalence

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 9, 2004, Pages 611-617

  Koytchev, Rossen ^a   Ozalp, Yildiz ^b   Erenmemisoglu, Aydin ^c   Van Der Meer, Mike John ^d   Alpan, Recep Serdar ^b  

^a Cooperative Clinical Drug Research and Development ^*  (Germany)

^b EIS Eczaciba i Ilac Sanayi ve Ticaret AS   (Turkey)

^c ERCIYES UNIVERSITY MEDICAL FACULTY   (Turkey)

^d Trident Bioanalytics Ltd   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

2 BUTYL 4 CHLORO 1 [[2' (1H TETRAZOL 5 YL) 4 BIPHENYLYL]METHYL] 5 IMIDAZOLECARBOXYLIC ACID; DRUG METABOLITE; HYDROCHLOROTHIAZIDE PLUS LISINOPRIL; LOSARTAN; SARVAS; SARVASTAN; ANTIHYPERTENSIVE AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HYDROCHLOROTHIAZIDE;

ADULT; APHTHOUS STOMATITIS; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG TOLERANCE; DYSPEPSIA; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HYPOTENSION; IN VIVO STUDY; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM ALLOWABLE CONCENTRATION; NAUSEA; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SLEEP DISORDER; SYNCOPE; TABLET FORMULATION; VOMITING; ADOLESCENT; CHEMISTRY; DRUG COMBINATION; HALF LIFE TIME; PHARMACOKINETICS; TABLET;

ADOLESCENT; ADULT; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; DRUG COMBINATIONS; HALF-LIFE; HUMANS; HYDROCHLOROTHIAZIDE; LOSARTAN; MALE; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 4644280565     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297058     Document Type: Article

References (19)

1. Siegl, P., Discovery of losartan, the first specific non-peptide angiotensin II receptor antagonist. J. Hypertens. 11 (Suppl. 3), S19 (1993)
2. Brunner, H. R., Nussberger, J., Waeber, B., Angiotensin II blockade compared with other pharmacological methods of inhibiting the renin-angiotensin system. J. Hypertens. 11 (Suppl. 3), S53 (1993)
3. Dzau, V. J., Sasamura, H., Hein, L., Heterogeneity of angiotensin synthetic pathways and receptor subtypes: physiological and pharmacological implications. J. Hypertens. 11 (Suppl. 3), S13 (1993)
4. Sweet, C. S., Nelson, E. B., How well have animal studies with losartan predicted responses in humans? J. Hypertens. 11 (Suppl. 3), S63 (1993)
5. Lo, M. W., Goldberg, M. R., McCrea, J. B. et al., Pharmacokinetics of losartan, an angiotensin II receptor antagonist, and its active metabolite EXP3174 in humans. Clin. Pharmacol. Ther. 58, 641 (1995)
6. Munger, M. A., Furniss, S. M., Angiotensin II receptor blockers: novel therapy for heart failure? Pharmacotherapy 16 (Suppl.), 59S (1996)
7. Ohtawa, M., Takayama, F., Saitoh, K. et al., Pharmacokinetics and biochemical efficacy after single and multiple oral administration of losartan, an orally active nonpeptide angiotensin II receptor antagonist in humans. Br. J. Clin. Pharmacol. 35, 290 (1993)
8. Gilman, A. G., Rall, T. W., Nies, A. S. (eds.), Goodman and Gilmanʼns The Pharmacological Basis of Therapeutics, 9th ed., Pergamon Press, New York (1996)
9. Breemann, B., Groschinsky-Grind, M., Pharmacokinetics of hydrochlorothiazide in man. Eur. J. Clin. Pharmacol. 12, 297 (1976)
10. Shah, V. P., Midha, K. K., Dighe, S. et al., Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharmaceut. Sci. 81, 309 (1992)
11. Hauschke, D., Steinijans, V., Diletti, E., A distribution free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 28, 72 (1990)
12. Zaidenstein, R., Soback, S., Gips, M. et al., Effect of grapefruit juice on the pharmacokinetics of losartan and its active metabolite E3174 in healthy volunteers. Ther. Drug Monit. 23, 369 (2001)
13. CPMP Note for guidance: Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 (1998)
14. Munafo, A., Christen, Y., Nussberger, J. et al., Drug concentration response relationships in normal volunteers after oral administration of losartan, an angiotensin II receptor antagonist. Clin. Pharmacol. Ther. 51, 513 (1992)
15. Dollery C. (ed.), Therapeutic Drugs, Churchill Livingstone, Edinburgh-London etc. (1999)
16. Arcuri, K., Harm, S., Nelson, E. et al., Efficacy and safety of concomitant losartan/hydrochlorothiazide therapy in patients with essential hypertension. Am. J. Hypertens. 7, 110A (1994)
17. Soffer, B. A., Wright, J., Pratt, J. H. et al., Antihypertensive effect of the combination therapy with losartan and hydrochlorothiazide in mild to severely hypertensive patients who are not adequately controlled on HCTZ alone. Am. J. Hypert-ens. 7, 42A (1994)
18. Goa, K. L., Wagstaff, A. J., Losartan potassium: a review of its pharmacology, clinical efficacy and tolerability in the management of hypertension. Drugs 51, 820 (1996)
19. Gardman, A. H., Arcuri, K. E., Goldberg, A. I. et al., A randomised, placebo-controlled, double-blind, parallel study ofvarious doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension 25, 1345 (1995)