A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet

Current Medical Research and Opinion

Volumn 22, Issue 10, 2006, Pages 1893-1897

  Ibanez Y ^a,b   Rodriguez J M ^a,b   Lujan M ^a,b   Grattan, T J ^c   Martin, A J ^c   Burnett, Ian ^c  

^a UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO   (Mexico)

^b UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO   (Mexico)

^c GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Paracetamol; Pharmacokinetic; Rate of absorption; Sodium bicarbonate

Indexed keywords

BICARBONATE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL;

ADULT; ANALGESIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASIA; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG TOLERABILITY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; SOUTH AMERICA; TABLET FORMULATION; ULTRAVIOLET RADIATION;

ABSORPTION; ACETAMINOPHEN; ADULT; ANALGESICS, NON-NARCOTIC; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; SODIUM BICARBONATE; TABLETS;

EID: 33750522243     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X132596     Document Type: Article

References (17)

1. Prescott LF. Paracetamol: past, present and future. Am J Ther 2000;7:143-7
2. Borin MT, Ayres JW. Single dose bioavailability of paracetamol following oral administration. Int J Pharm 1989;54:199-209
3. Nielsen JC, Bjerring P, Arent-Nielsen L. A comparison of the hypoalgesic effect of paracetamol in slow-release and plain tablets on laser induced pain. Br J Clin Pharmacol 1991;31:267-70
4. Rygnestad T, Zahlsen K, Samdal FA. Absorption of effervescent paracetamol tablets relative to ordinary paracetamol tablets. Eur J Clin Pharmacol 2000;56:141-3
5. Moeller PL, Norholt SE, Ganry HE, et al. Time to onset of analgesia and analgesic efficacy of effervescent paracetamol 1000 mg compared to tablet acetaminophen 1000 mg in postoperative dental pain: a randomized placebo-controlled study. J Clin Pharmacol 2000;40:370-8
6. Rostami-Hodjegan A, Shiran MR, Ayesh R, et al. A new rapidly absorbed paracetamol tablet containing sodium bicarbonate. I. A four-way cross-over study to compare the concentration-time profile of paracetamol from the new paracetamol/sodium bicarbonate tablet and a conventional paracetamol tablet in fed and fasted volunteers. Drug Dev Ind Pharm 2002;28:523-31
7. Kelly K, O'Mahony B, Lindsay B, et al. Comparison of the rates of disintegration, gastric emptying, and drug absorption following administration of a new and a conventional paracetamol formulation, using γ scintigraphy. Pharm Res 2003;20:1668-73
8. Jones B, Kenward KG. Design and analysis of cross-over trials. CRC Press, 1989, p. 151-204
9. Data on file, UNAM (Universidad Nacional Autonoma de Mexico)
10. Hills M, Armitage P. The two period cross-over clinical trial. Br J Clin Pharmacol 1979;8:7-20
11. Hollander M, Wolfe DA. Non-parametric statistical methods. New York: Wiley; 1973. p. 75-82
12. FDA Guidance Document (1999). Guidance for industry: average, population, and individual approaches to establishing bioequivalence. Rockville (MD): US Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 1999
13. Hunt JN, Pathak JD. The osmotic effects of some simple molecules and ions on gastric emptying. J Physiol 1960;154:254-69
14. Bell FR, Mostaghni K. Duodenal control of gastric emptying in the milk-fed calf. J Physiol 1975;245:387-407
15. Personal communication, Professor CG Wilson, Strathclyde University, UK
16. FDA. Guidance for industry. Bioavailability and bioequivalence studies for orally administered products - general considerations. March 2003
17. Schachtel BP, Loose I, Brown AT, et al. Onset of action defined by patients. Clin Pharmacol Ther 1999;65:117