[Studies of the pharmacokinetics and bioavailability of a new trimethoprim/sulfamethoxazole preparation in healthy volunteers].
The objective of this study was to determine both the pharmacokinetic parameters and the bioavailability of a newly developed trimethoprim/sulfamethoxazole preparation (cotrimoxazole, Kepinol forte, 160 mg of trimethoprim/800 mg of sulfamethoxazole) in comparison with a reference preparation customary in trade and registered according to the AMG 1976, after single oral administration. For this purpose the test and the reference preparation were examined in a randomized 2-way crossover design (Latin square) in 12 volunteers each. Both dosage forms led to maximum plasma levels of approx. 1250 ng/ml of trimethoprim and about 40 micrograms/ml of sulfamethoxazole 1.5-2 h after application; the plasma half-lives were about 9 h for trimethoprim and around 8.5 h for sulfamethoxazole. The statistical comparison (ANOVA, confidence intervals according to Westlake, Pratt-Wilcoxon test) of the pharmacokinetic parameters found in the study resulted in bioequivalence of the newly developed trimethoprim/sulfamethoxazole preparation and the reference preparation. Furthermore, after the administration of both preparations no marked side effects worth mentioning were observed, suggesting a good and comparable clinical tolerability of the two preparations.
Hutt
V
V
LAB Gesellschaft für pharmakologische Untersuchungen mbH & Co., Neu-Ulm.
Klingmann
I
I
Pabst
G U
GU
Salama
Z
Z
Nieder
M
M
Jaeger
H
H
D000328:Adult; D000704:Analysis of Variance; D001682:Biological Availability; D004338:Drug Combinations / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D013420:Sulfamethoxazole / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013607:Tablets; D014295:Trimethoprim / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D015662:Trimethoprim, Sulfamethoxazole Drug Combination
D004338:Drug Combinations; D013607:Tablets; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D014295:Trimethoprim; D013420:Sulfamethoxazole
Untersuchungen zur Pharmakokinetik und Bioverfügbarkeit einer neuen Trimethoprim/Sulfamethoxazol-Zubereitung an gesunden Freiwilligen.