Bioequivalence assessment of ambroxol tablet after a single oral dose administration to healthy male volunteers

Pharmacological Research

Volumn 49, Issue 1, 2004, Pages 93-98

  Lee, Hee Joo ^a,b   Joung, Sun Koung ^b   Kim, Yoon Gyoon ^c   Yoo, Jeong Yeon ^b   Han, Sang Beom ^a,b  

^a Seoul Medical Science Institute   (South Korea)

^b BioCore Co Ltd   (South Korea)

^c Dankook University   (South Korea)

Author keywords

Ambroxol; Bioequivalence study; Pharmacokinetics; Volunteers

Indexed keywords

ACETYLCYSTEINE; AMBROXOL; ROISOL;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG MONITORING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PARAMETRIC TEST; PRIORITY JOURNAL; TABLET FORMULATION;

EID: 0142184377     PISSN: 10436618     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.phrs.2003.07.011     Document Type: Article

References (16)

1. Nemcekova E., Nosalova G., Franova S. Ambroxol and protective reflexes of respiratory tract. Bratisl. Lek. Listy. 99:1998;111-115.
2. Pfeifer S., Zissel G., Kienast K., Muller-Quernheim J. Reduction of cytokine release of blood and bronchoalveolar mononuclear cells by ambroxol. Eur. J. Med. Res. 24:1997;129-132.
3. Severina I.S., Bussygina O.G., Pyatakova N.V., Khropov Y.V., Krasnoperov R.A. Ambroxol as an inhibitor of nitric oxide-dependent activation of soluble guanylate cyclase. Eur. J. Pharmacol. 407:2000;61-64.
4. Guyatt G.H., Gordon H., Townsend M., Kazim B.A.F., Newhouse M.T. A controlled trial of ambroxol in chronic bronchitis. Chest. 92:1987;618.
5. Sweet D.G., Halliday H.L. Current perspectives on the drug treatment of neonatal respiratory distress syndrome. Paediatr Drugs. 1:1999;19-30.
6. Nobilis M., Pastera J., Svoboda D., Kvetina J., Macek K. High-performance liquid chromatographic determination of ambroxol in human plasma. J. Chromatogr. 581:1992;251-255.
7. Couet W., Girault J., Reigner B.G., Ingrand I., Bizouard J., Acerbi D.et al. Steady-state bioavailability and pharmacokinetics of ambroxol and clenbuterol administered alone and combined in a new oral formulation. Int. J. Clin. Pharmacol. Ther. Toxicol. 27:1989;467-472.
8. Vergin H., Bishop-Freudling G.B., Miczka M., Nitsche V., Strobel K., Matzkies F. The pharmacokinetics and bioequivalence of various dosage forms of ambroxol. Arzneimittelforschung. 35:1985;1591-1595.
9. Janssen T.J., Guelen P.J.M., Vree T.B., Botterblom M.H.A., Valducci R. Bioavailability of ambroxol sustained release preparations. Part II. Single and multiple oral dose studies in man. Arzneimittelforschung. 38:1988;95-97.
10. Diletti E., Hauschke D., Steinijans V.W. Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 29:1991;1-8.
11. Flores-Murrieta F.J., Hoyo-Vadillo C., Hong E., Castaneda-Hernandez G. Assay of ambroxol in human plasma by high-performance liquid chromatography with amperometric detection. J. Chromatogr. 490:1989;464-469.
12. Chiou W.L. Critical evaluation of the potential error in pharmacokinetic studies of using the linear trapezoidal rule method for the calculation of the area under the plasma level-time curve. J. Pharmacokinet Biopharm. 6:1978;539-546.
13. Hauschke D., Steinjans V.W., Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 28:1990;72-78.
14. Sauter R., Steinijans V.W., Diletti E., Bohm A., Schulz H.U. Presentation of results from bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 30:1992;233-256.
15. Wijnand H.P. Assessment of average, population and individual bioequivalence in two- and four-period crossover studies. Comput. Methods Programs Biomed. 70:2003;21-35.
16. Marzo A., Ceppi Monti N., Vuksic D. Experimental, extrapolated and truncated areas under the concentration-time curve in bioequivalence trials. Eur. J. Clin. Pharmacol. 55:1999;627-631.