Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers

Arzneimittel-Forschung/Drug Research

Volumn 53, Issue 4, 2003, Pages 260-265

  Lücker, Peter Wolfgang ^a   Birkel, Manfred ^a   Hey, Bernhard ^a   Loose, Irene ^b   Schaefer, Andrea ^a  

^a Inst Klin Pharmakol B   (Germany)

^b BAYER AG   (Germany)

Author keywords

Acetylsalicylic acid, combination with pseudoephedrine, interaction; CAS 50 78 2; CAS 90 82 4; Pseudoephedrine, combination with acetylsalicylic acid, interaction

Indexed keywords

ACETYLSALICYLIC ACID; CAS 50 78 2; CAS 69 72 7; CAS 90 82 4; PSEUDOEPHEDRINE; SALICYLIC ACID;

ADULT; ANALYSIS OF VARIANCE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG SAFETY; DRUG TOLERABILITY; GEOMETRY; HUMAN; LATIN SQUARE DESIGN; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL;

EID: 0038407901     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297106     Document Type: Article

References (11)

1. Martindale. The complete drug reference. 32st Ed., pp. 1068-1069, The Pharmaceutical Press, London (1999)
2. Martindale. The complete drug reference. 32st Ed., pp. 16-19, The Pharmaceutical Press, London (1999)
3. Lorbeer, B., The common cold. J. Eur. Intern. Med. 11, 229 (1996)
4. Gwaltney, J. M. Jr., Rhinovirus. In: G. L. Mandell et al. (eds.), Principles and Practice of Infectious Diseases. 3rd Ed., pp. 1399-1405, Churchill Livingstone, New York (1990)
5. World Medical Association: Declaration of Helsinki: Ethical principles for medical research involving human subjects as revised in Edinburgh, Scotland (October 2000)
6. "Gesetz über den Verkehr mit Arzneimitteln (AMG) in der Fassung des Gesetzes zur Neuordnung des Arzneimittelrechts" of 1976 as revised July 2000
7. CPMP/ICH/135/95 Note for Guidance on Good Clinical Practice, January 17, 1997
8. Miners, J. O., Drug interactions involving aspirin (acetylsalicylic acid) and salicylic acid. Clin. Pharmacokinet. 17, 327 (1989)
9. Wellington, K., Jarvis, B., Cetirizine/Pseudoephedrine. Drugs 61, 2231 (2001)
10. Kosoglou, T., Radwanski, E., Batra, V. K. et al., Pharmacokinetics of loratadine and pseudoephedrine following single and multiple doses of once- versus twice-daily combination tablet formulations in healthy adult males. Clin. Ther. 19, 1002 (1997)
11. CPMP/EWP/240/95 Note for Guidance on Fixed Combination Medicinal Products (CPMP adopted April 1996)