A 3-way crossover study to evaluate the pharmacokinetic interaction between nateglinide and diclofenac in healthy volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 40, Issue 10, 2002, Pages 457-464

  Anderson, D M ^a   Shelley, S ^a   Crick, N ^a   Buraglio, M ^a  

^a GCP Management Services Limited   (United Kingdom)

Author keywords

Diclofenac; Drug drug interaction; Nateglinide; NSAID

Indexed keywords

DICLOFENAC; FLURBIPROFEN; GLUCOSE; INSULIN; NATEGLINIDE; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL ANTIDIABETIC AGENT;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DATA ANALYSIS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; HEADACHE; HUMAN; HUMAN EXPERIMENT; INSULIN RELEASE; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; RHEUMATIC DISEASE; VOLUNTEER;

EID: 0036792671     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP40457     Document Type: Article

References (20)

1. Choudhury S, Hirschberg Y, Filipek R et al 2000 Single-dose pharmacokinetics of nateglinide in subjects with hepatic cirrhosis. J Clin Pharmacol 40: 634-640
2. Hanefeld M, Dickinson S, Bouter KP, Guitard C 2000 Rapid and short-acting mealtime insulin secretion with nateglinide controls both prandial and mean glycemia. Diabetes Care 23: 202-207
3. Haniff, Kumar S 2001 Nateglinide: a new rapid-acting insulinotropic agent. Exp Opin Pharmacother 2: 1027-1031
4. Hirose H, Maruyama H, Ito K, Seto Y, Kido K, Koyama K et al 1994 Effects of N-[(trans-4-isopropyleyclohexyl)-carbonyl]-D-phenylalanine (A-4166) on insulin and glucagon secretion in isolated perfused rat pancreas. Pharmacology 48: 205-210
5. Hirschberg Y, Karara AH, Pietri AO, McLeod JF 2000 Improved control of mealtime glucose excursions with coadministration of nateglinide and metformin. Diabetes Care 23: 349-353
6. Ikenoue T, Akiyoshi M, Fulitani S, Okazaki K, Kondo N, Maki T 1997 Hypoglycemic and insulinotropic effects of a novel oral antidiabetic agent (-)-N-[trans-4-isopropylcyclohexyl)-carbonyl]-D-phenylalanine (A-4166). Br J Pharmacol 120: 137-145
7. Karara AH, Dunning BE, McLeod JF 1999 The effect of food on the oral bioavailability and the pharmacodynamic actions on the insulinotropic actions of the agent nateglinide in healthy subjects. J Clin Pharmacol 39: 172-179
8. Keilson L, Mather S, Walter YH, Subramanians, McLeod JF 2000 Synergistic effects of nateglinide and meal administration on insulin secretion in patients with type 2 diabetes mellitus. J Clin Endocrinol Metab 85: 1081-1086
9. Kikuchi M 1996 Modulation of insulin secretion in non-insulin-dependent diabetes mellitus by two novel oral hypoglycemic agents, NN623 and A-4166. Diabet Med 13 (Suppl 6): S151-S155
10. Leemann T, Transon C, Dayer P 1993 Cytochrome P450TB (CYP2C): a major monooxygenase catalyzing diclofenac 4'-hydoxylation in human liver. Life Sci 52: 24-29
11. Mascher H 1989 The pharmacokinetics of a new sustained-release form of diclofenac sodium in humans. Drugs Dev Defiv 4: 303-311
12. Ono I, Matsuda K, Kanno S 1996 Determination of N-[(trans-4-isopropylcyclohexyl)-carbonyl]-D-phenylalanine in human plasma by solid-phase extraction and column-switching high performance liquid chromatography with ultraviolet detection. J Chromatogr B 678: 384-387
13. Sato Y, Nishikawa M, Shinkai H, Sukegawa E 1991 Possibility of ideal blood glucose control by a new oral hypoglycemic agent, N-[(trans-4-isopropylcyclohexyl)-carbonyl]-D-phenylalanine (A-4166), and its stimulatory effect on insulin secretion in animals. Diab Res Clin Pract 12: 53-59
14. Sato Y, Nishikawa M, Shinkai H 1988 High performance liquid chromatographic method for quantitation of a new antidiabetic agent in plasma. J Liq Chromatogr 11: 3425-3433
15. Takesada H, Matsuda K, Ohtake R, Mihara R, Ono I, Tanaka K, Naito M, Yatagai M et al 1996 Structure determination of metabolites isolated from urine and bile after administration of AY-4166, a novel D-phenylalanine-derivative hypoglycemic agent. Bioorg Med Chem 4: 1771-1781
16. Todd PA, Sorkin EM 1988 Diclofenac sodium re-appraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy. Drugs 35: 244-285
17. Walter YH, Sprott DI, Garreffa S, McLeod JF 2000 Mealtime glucose regulation by nateglinide in type 2 diabetes mellitus. Eur J Clin Pharmacol 56: 129-133
18. Ward WK, Beard JC, Halter JB, Pfeiffer MA, Porte D 1984 Pathophysiology of insulin secretion in non-insulin-dependent diabetes mellitus. Diabetes Care 7: 491-502
19. Whitelaw DC, Clark PM, Smith JM, Nattrass M 2000 Effects of the new oral hypoglycemic agent nateglinide on insulin secretion in type 2 diabetes. Diabet Med 17: 225-229
20. Willis JV, Kendall MJ, Jack DB 1981 The influence of food on the absorption of diclofenac after single and multiple oral doses. Eur J Clin Pharm 19: 33-37