[Studies on the bio-availability of tolbutamide (author's transl)].
Two different batches of Rastinon 1,0 Hoechst were administered, a year apart, to two groups of healthy subjects (ten and six men, respectively) without any difference in effect on blood sugar being found. The blood sugar concentration was measured in six healthy men before and after oral administration of 1,000 mg tolbutamide (as Rastinon 1,0 Hoechst or tolbutamid tablets Ratiopharm), in a blind test. After tolbutamide Ratiopharm, the area under the blood sugar concentration-time curves was only 29 percent (0-4 hafter medication) and 32 percent (4-8 h after medication) of that after Rastinon 1,0 (P 2alpha less than 0.01), with marked scatter between individuals. Maximal serum concentration was 80 percent below that after Rastinon. The first measurable value was reached 0.8 plus or minus 0.2 h after medication of Rastinon and 3.6 plus or minus 0.8 h after tolbutamide Ratiopharm. The areas under the serum concentration under the curves after tolbutamide Ratiopharm were only 16 percent (0-4 h after medication) and 19 percent (0-8 h after medication) of those after Rastinon (P 2alpha less than 0.05 and 0.01, respectively). The differences demonstrate that tolbutamide Ratiopharm tablets and Rastinon 1,0 Hoechst are not equivalent biologically and therapeutically.
D000284:Administration, Oral; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014044:Tolbutamide / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*
D001786:Blood Glucose; D014044:Tolbutamide
Untersuchungen zur Bioäquivalenz von Tolbutamid