Pharmacokinetics and bioequivalence evaluation of three commercial tablet formulations of mefloquine when given in combination with dihydroartemisinin in patients with acute uncomplicated falciparum malaria

European Journal of Clinical Pharmacology

Volumn 55, Issue 10, 2000, Pages 743-748

  Na Bangchang, K ^a   Karbwang, J ^a   Palacios, P A C ^a   Ubalee, R ^a   Saengtertsilapachai, S ^b   Wernsdorfer, W H ^c  

^a MAHIDOL UNIVERSITY   (Thailand)

^b MAHIDOL UNIVERSITY   (Thailand)

^c UNIVERSITY OF VIENNA   (Austria)

Author keywords

Bioequivalence; Dihydroartemisinin; Mefloquine; Pharmacokinetics; Uncomplicated falciparum malaria

Indexed keywords

DIHYDROARTEMISININ; ELOQUIN 250; LACTAB; MEFLOQUINE; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG TOLERABILITY; FOLLOW UP; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; HUMAN TISSUE; MALARIA FALCIPARUM; PRIORITY JOURNAL; THAILAND;

EID: 0033956599     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002280050008     Document Type: Article

References (17)

1. 1. Wernsdorfer WH (1994) Epidemiology of drug resistance in malaria. Acta Trop 56: 143-146
2. 2. Weidekamm E, Rusing G, Caplain H, Sorgel F, Crevoisier C (1998) Lack of bioequivalence of a generic mefloquine tablet with the standard product. Eur J Clin Pharmacol 54: 615-619
3. 3. Karbwang J, Molunto P, Na-Bangchang K, Bunnag D (1989) Determination of mefloquine in biological fluids by high performance liquid chromatography. Southeast Asian J Trop Med Public Health 20: 55-60
4. 4. Gibaldi M (1991) Biopharmaceutics and clinical pharmaco-kinetics, 4th edn. Lea and Febiger, UK, pp 14-23
5. 5. Schuirmann DJ (1987) A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15: 657-680
6. 6. Food and Drug Administration (1992) FDA guidance: Statistical procedures for bioequivalence studies using a standard two-treatment cross-over design. Food and drug administration, Washington DC
7. 7. Karbwang J, White NJ (1990) Clinical pharmacokinetics of mefloquine. Clin Pharmacokinet 19: 264-279
8. 8. Karbwang J, Back DJ, Bunnag D, Breckenridge AM (1988) A comparison of the pharmacokinetics of mefloquine in healthy Thai volunteers and in Thai patients with falciparum malaria. Eur J Clin Pharmacol 35: 677-680
9. 9. Boudreau EF, Fleckenstein L, Pang LW, Childs GE, Schroder AC, Ratnaratorn B, Phintuyothin P (1990) Mefloquine kinetics in cured and recrudescent patients with acute falciparum malaria and in healthy volunteers. Clin Pharmacol Ther 48: 399-409
10. 10. Na-Bangchang K, Molunto P, Banmairuroi V, Thanavibul A, Karbwang J (1995) Pharmacokinetics of mefloquine when given as a single and two divided-dose regimens. Int J Clin Pharmacol Res XV: 215-220
11. 11. Desjardins RE, Pamplin CL, Von Bredow J, Barry KG, Canfield CJ (1979) Kinetics of a new antimalarial, mefloquine. Clin Pharmacol Ther 26: 372-379
12. 12. Na-Bangchang K, Tippawangkosol P, Thanavibul A, Ubalee R, Karbwang J (1999) Pharmacokinetic and pharmacodynamic interactions of mefloquine and dihydroartemisinin. Int J Clin Pharmacol Res XIX: 9-18
13. 13. Crevoisier C, Handschin J, Barre J, Roumenov D, Kleinbloesem C (1997) Food increases the bioavailability of mefloquine. Eur J Clin Pharmacol 53: 135-139
14. 14. Karbwang J, Na-Bangchang K, Thanavibul A, Bunnag D, Harinasuta T (1991) Pharmacokinetics of mefloquine in treatment failure. Southeast Asian J Trop Med Public Health 22: 523-526
15. 15. Karbwang J, Na-Bangchang K, Thimasarn K, Rooney W, Bunnag D, Harinasuta T (1993) Mefloquine levels in patients with mefloquine resistant Plasmodium falciparum in the eastern part of Thailand. Southeast Asian J Trop Med Public Health 24: 226-229
16. 16. Lobel HO, Miani M, Eng T, Bernard KW, Hightower AW, Campbell CC (1993) Long-term malaria prophylaxis with mefloquine. Lancet 341: 848-851
17. 17. ter Kuile FO, Nosten F, Thieren D, Luxemburger C, Edstein MD, Chongsuphajaisiddhi T, Phaipun L, Webster HK, White NJ (1992) High dose mefloquine in the treatment of multi-drug resistant falciparum malaria. J Infect Dis 66: 1393-1400