Bioequivalence study of two formulations of enalapril, at a single oral dose of 20 mg (tablets): A randomized, two-way, open-label, crossover study in healthy volunteers

Current Therapeutic Research - Clinical and Experimental

Volumn 65, Issue 1, 2004, Pages 34-46

  Portolés, Antonio ^a   Terleira, Ana ^a   Almeida, Susana ^b   García Arenillas, Mar ^a   Caturla, Mari Cruz ^c   Filipe, August ^b   Vargas, Emilio ^a  

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^b Tecnimede Group   (Portugal)

^c MCC Analitica   (Spain)

Author keywords

bioavailability; bioequivalence; blood pressure; clinical trial; enalapril; enalaprilat; healthy volunteers; pharmacokinetics

Indexed keywords

ENALAPRIL; ENALAPRILAT;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD PRESSURE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FATIGUE; FEMALE; HALF LIFE TIME; HEADACHE; HUMAN; INTERVIEW; LABORATORY TEST; MALE; MEAN RESIDENCE TIME; NORMAL HUMAN; PHYSICAL EXAMINATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; TABLET FORMULATION;

EID: 3242739255     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0011-393X(04)90003-3     Document Type: Article

References (8)

1. Committee for Proprietary Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. 2001;. Available at: http://www.emea.eu.int. Accessed November 1, 2003
2. Chow S.C., Liu J.P. Design and Analysis of Bioavailability and Bioequivalence Studies. 2000;Marcel Dekker, New York
3. Todd P.A., Goa K.L. Enalapril. A reappraisal of its pharmacology and therapeutic use in hypertension. Drugs. 43:1992;346-381
4. Drug Information. 2001;American Hospital Formulary Service, American Society of Health-System Pharmacists, Inc, Bethesda, Md
5. Donnelly R., Meredith P.A., Elliott H.L., Reid J.L. Kinetic-dynamic relations and individual responses to enalapril. Hypertension. 15:1990;301-309
6. Todd P.A., Heel R.C. Enalapril. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in hypertension and congestive heart failure. Drugs. 31:1986;198-248
7. Ribeiro W., Muscará M.N., Martins A.R., et al. Bioequivalence study of two enalapril maleate tablet formulations in healthy male volunteers. Pharmacokinetic versus pharmacodynamic approach. Eur J Clin Pharmacol. 50:1996;399-405
8. US Food and Drug Administration. Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products - General considerations. 2003;. Available at http://www.fda.gov/cder/guidance/index/htm. Accessed November 1, 2003