Systemic exposure to rosiglitazone is unaltered by food
To evaluate the effect of food on the bioavailability and pharmacokinetics of the insulin sensitizer rosiglitazone. In a randomized, open-label, period-balanced, single-dose, crossover study, rosiglitazone 2 mg was administered to 12 healthy male volunteers either in the fasting state or following a...
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| Veröffentlicht in: | European journal of clinical pharmacology 1999-03, Vol.55 (1), p.53-56 |
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| creator | FREED, M. I ALLEN, A JORKASKY, D. K DICICCO, R. A |
| description | To evaluate the effect of food on the bioavailability and pharmacokinetics of the insulin sensitizer rosiglitazone.
In a randomized, open-label, period-balanced, single-dose, crossover study, rosiglitazone 2 mg was administered to 12 healthy male volunteers either in the fasting state or following a standard high-fat breakfast. The primary end points of the study were AUC(0-inf) and Cmax.
Single oral doses of rosiglitazone were safe and well tolerated. Overall exposure to rosiglitazone was unaffected by food. The geometric mean ratio of AUC(0-inf) in the fed:fasted regimens was 0.94 (95% CI: 0.82, 1.06); t1/2 was unaffected. Absorption of rosiglitazone in the fed state was more gradual and sustained than in the fasted state. Cmax was reduced by approximately 20% (point estimate 0.80; 95% CI 0.65 to 0.97) and tmax was modestly delayed in the fed state.
These data support dosing guidelines that will permit the administration of rosiglitazone without regard to meals for treatment of type 2 diabetes mellitus. |
| doi_str_mv | 10.1007/s002280050592 |
| format | Article |
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In a randomized, open-label, period-balanced, single-dose, crossover study, rosiglitazone 2 mg was administered to 12 healthy male volunteers either in the fasting state or following a standard high-fat breakfast. The primary end points of the study were AUC(0-inf) and Cmax.
Single oral doses of rosiglitazone were safe and well tolerated. Overall exposure to rosiglitazone was unaffected by food. The geometric mean ratio of AUC(0-inf) in the fed:fasted regimens was 0.94 (95% CI: 0.82, 1.06); t1/2 was unaffected. Absorption of rosiglitazone in the fed state was more gradual and sustained than in the fasted state. Cmax was reduced by approximately 20% (point estimate 0.80; 95% CI 0.65 to 0.97) and tmax was modestly delayed in the fed state.
These data support dosing guidelines that will permit the administration of rosiglitazone without regard to meals for treatment of type 2 diabetes mellitus.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s002280050592</identifier><identifier>PMID: 10206085</identifier><language>eng</language><publisher>Heidelberg: Springer</publisher><subject>Adolescent ; Adult ; Bioavailability ; Biological and medical sciences ; Clinical trials ; Cross-Over Studies ; Data processing ; Diabetes mellitus ; Dietary Fats - pharmacology ; Drug therapy ; Fasting ; Food ; Food-Drug Interactions - physiology ; Hormones. Endocrine system ; Humans ; Hypoglycemic Agents - blood ; Insulin ; Male ; Medical sciences ; Pharmacokinetics ; Pharmacology. Drug treatments ; Rosiglitazone ; Thiazoles - adverse effects ; Thiazoles - blood ; Thiazolidinediones</subject><ispartof>European journal of clinical pharmacology, 1999-03, Vol.55 (1), p.53-56</ispartof><rights>1999 INIST-CNRS</rights><rights>Springer-Verlag Berlin Heidelberg 1999</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c379t-e18f520296f6854578775ba83a0fb6c19230711d5fec96a1cd27281f15ee2b533</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1722240$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10206085$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>FREED, M. I</creatorcontrib><creatorcontrib>ALLEN, A</creatorcontrib><creatorcontrib>JORKASKY, D. K</creatorcontrib><creatorcontrib>DICICCO, R. A</creatorcontrib><title>Systemic exposure to rosiglitazone is unaltered by food</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><description>To evaluate the effect of food on the bioavailability and pharmacokinetics of the insulin sensitizer rosiglitazone.
In a randomized, open-label, period-balanced, single-dose, crossover study, rosiglitazone 2 mg was administered to 12 healthy male volunteers either in the fasting state or following a standard high-fat breakfast. The primary end points of the study were AUC(0-inf) and Cmax.
Single oral doses of rosiglitazone were safe and well tolerated. Overall exposure to rosiglitazone was unaffected by food. The geometric mean ratio of AUC(0-inf) in the fed:fasted regimens was 0.94 (95% CI: 0.82, 1.06); t1/2 was unaffected. Absorption of rosiglitazone in the fed state was more gradual and sustained than in the fasted state. Cmax was reduced by approximately 20% (point estimate 0.80; 95% CI 0.65 to 0.97) and tmax was modestly delayed in the fed state.
These data support dosing guidelines that will permit the administration of rosiglitazone without regard to meals for treatment of type 2 diabetes mellitus.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Bioavailability</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>Data processing</subject><subject>Diabetes mellitus</subject><subject>Dietary Fats - pharmacology</subject><subject>Drug therapy</subject><subject>Fasting</subject><subject>Food</subject><subject>Food-Drug Interactions - physiology</subject><subject>Hormones. Endocrine system</subject><subject>Humans</subject><subject>Hypoglycemic Agents - blood</subject><subject>Insulin</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. 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I</au><au>ALLEN, A</au><au>JORKASKY, D. K</au><au>DICICCO, R. A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Systemic exposure to rosiglitazone is unaltered by food</atitle><jtitle>European journal of clinical pharmacology</jtitle><addtitle>Eur J Clin Pharmacol</addtitle><date>1999-03-01</date><risdate>1999</risdate><volume>55</volume><issue>1</issue><spage>53</spage><epage>56</epage><pages>53-56</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>To evaluate the effect of food on the bioavailability and pharmacokinetics of the insulin sensitizer rosiglitazone.
In a randomized, open-label, period-balanced, single-dose, crossover study, rosiglitazone 2 mg was administered to 12 healthy male volunteers either in the fasting state or following a standard high-fat breakfast. The primary end points of the study were AUC(0-inf) and Cmax.
Single oral doses of rosiglitazone were safe and well tolerated. Overall exposure to rosiglitazone was unaffected by food. The geometric mean ratio of AUC(0-inf) in the fed:fasted regimens was 0.94 (95% CI: 0.82, 1.06); t1/2 was unaffected. Absorption of rosiglitazone in the fed state was more gradual and sustained than in the fasted state. Cmax was reduced by approximately 20% (point estimate 0.80; 95% CI 0.65 to 0.97) and tmax was modestly delayed in the fed state.
These data support dosing guidelines that will permit the administration of rosiglitazone without regard to meals for treatment of type 2 diabetes mellitus.</abstract><cop>Heidelberg</cop><cop>Berlin</cop><pub>Springer</pub><pmid>10206085</pmid><doi>10.1007/s002280050592</doi><tpages>4</tpages></addata></record> |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adolescent Adult Bioavailability Biological and medical sciences Clinical trials Cross-Over Studies Data processing Diabetes mellitus Dietary Fats - pharmacology Drug therapy Fasting Food Food-Drug Interactions - physiology Hormones. Endocrine system Humans Hypoglycemic Agents - blood Insulin Male Medical sciences Pharmacokinetics Pharmacology. Drug treatments Rosiglitazone Thiazoles - adverse effects Thiazoles - blood Thiazolidinediones |
| title | Systemic exposure to rosiglitazone is unaltered by food |
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