Effect of the combination of lisinopril and hydrochlorothiazide on the bioequivalence of tablet formulations

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 9 A, 2004, Pages 605-610

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

^a Coop Clin Drug R and D ^*  (Germany)

^b EIS Eczacibasi Ilac Sanayi ve T   (Turkey)

^c ERCIYES UNIVERSITY   (Turkey)

^d Trident Bioanalytics Ltd   (Ireland)

^e Coop Clin Drug R and D AG ^*  (Germany)

Author keywords

CAS 58 93 5; CAS 83915 83 7; Lisinopril, bioequivalence, clinical pharmacokinetics, combination with hydrochlorothiazide; Sinopryl ; Sinoretik

Indexed keywords

HYDROCHLOROTHIAZIDE PLUS LISINOPRIL; LISINOPRIL; SINOPRYL; SINORETIK;

ADULT; ALLERGIC REACTION; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; COLIC; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HYPERSENSITIVITY; DRUG TOLERABILITY; FEVER; HEADACHE; HERPES LABIALIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; MASS SPECTROMETRY; MAXIMUM ALLOWABLE CONCENTRATION; NAUSEA; NORMAL HUMAN; OPEN STUDY; PAPULAR SKIN DISEASE; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SYNCOPE; TABLET FORMULATION; TONSILLITIS; VOMITING;

EID: 4644234283     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297057     Document Type: Article

References (18)

1. Gilman, A. G., Rall, T. W., Nies, A. S. (eds.), Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed. Pergamon Press, New York (1996)
2. McAreavey, D., Robertson, J. I., Angiotensin converting enzyme inhibitors and moderate hypertension. Drugs 40, 326 (1990)
3. Dusing, R., Kayser, G., Wagner, S. et al., Baroreflex setting and sensitivity in normal subjects: effects of pharmacologic inhibition of the angiotensin I converting enzyme. Am. J. Cardiol. 59, 50D (1987)
4. Sugimoto, K., Kumagai, Y., Tateishi, T. et al., Effects on autonomic function of a new angiotensin converting enzyme inhibitor, ramipril. J. Cardiovasc. Pharmacol. 13 (Suppl. 3), S40 (1989)
5. Goa, K. L., Balfour, J. A., Zuanetti, G., A review of its pharmacology and clinical efficacy in the early management of acute myocardial infarction. Drugs 52, 564 (1996)
6. Goa, K. L., Haria, M., Wilde, M. I., Lisinopril. A review of its pharmacology and use in the management of the complications of diabetes mellitus. Drugs 53, 1081 (1997)
7. Simpson, K., Jarvis, B., Lisinopril. A review of its use in congestive heart failure. Drugs 59, 1149 (2000)
8. Breemann, B., Groschinsky-Grind, M., Pharmacokinetics of hydrochlorothiazide in man. Eur. J. Clin. Pharmacol. 12, 297 (1976)
9. Chrysant S. G., Antihypertensive effectiveness of low-dose lisinopril-hydrochlorothiazide combination: a large multicenter study. Arch. Intern. Med. 154, 737 (1994)
10. Dal Palu, C., Lisinopril versus hydrochlorothiazide in mild-to-moderate systolic/diastolic or isolated systolic hypertension in the elderly. Curr. Ther. Res. 54, 779 (1993)
11. Shah, V. P., Midha, K. K., Dighe, S. et al., Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharmaceut. Sci. 81, 309 (1992)
12. 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)
13. Chodoff, L., Lisinopril: a new ACE inhibitor for the treatment of hypertension and congestive heart failure. Mt. Sinai J. Med. 57, 169 (1990)
14. CPMP Note for guidance: Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 (1998)
15. Hart, W., Lisinopril-hydrochlorothiazide combination compared with monocomponents in elderly hypertensive patients. J. Hum. Hypertens. 5 (Suppl. 2), 85 (1991)
16. Miller, W., Introduction to lisinopril-hydrochlorothiazide combination. J. Hum. Hypertens. 5 (Suppl. 2), 49 (1991)
17. Murray, N. H., Review of international safety data for lisinopril-hydrochlorothiazide combination treatment. J. Hum. Hypertens. 5 (Suppl. 2), 63 (1991)
18. Swaisland, A. J., The pharmacokinetics of co-administered lisinopril and hydrochlorothiazide. J. Hum. Hypertens. 5 (Suppl. 2), 69 (1991)