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The pharmacodynamic...
The pharmacodynamics, safety and pharmacokinetics of single doses of the motilin agonist, camicinal, in type 1 diabetes mellitus with slow gastric emptying
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- Hellström, Per M. (författare)
- Uppsala universitet,Gastroenterologi/hepatologi
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- Tack, Jan (författare)
- Univ Leuven, Louvain, Belgium.
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- Johnson, Lakshmi Vasist (författare)
- GlaxoSmithKline, Res Triangle Pk, NC USA.
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- Hacquoil, Kimberley (författare)
- GlaxoSmithKline, Stevenage, Herts, England.
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- Barton, Matthew E. (författare)
- GlaxoSmithKline, Res Triangle Pk, NC USA.
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- Richards, Duncan B. (författare)
- GlaxoSmithKline, Stevenage, Herts, England.
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- Alpers, David H. (författare)
- Washington Univ, Sch Med, St Louis, MO USA.
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- Sanger, Gareth J. (författare)
- Queen Mary Univ London, Barts & London Sch Med & Dent, London, England.
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- Dukes, George E. (författare)
- GlaxoSmithKline, Res Triangle Pk, NC USA.
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(creator_code:org_t)
- 2016-04-13
- 2016
- Engelska.
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Ingår i: British Journal of Pharmacology. - : Wiley. - 0007-1188 .- 1476-5381. ; 173:11, s. 1768-1777
- Relaterad länk:
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https://bpspubs.onli...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- BACKGROUND AND PURPOSE Here we have investigated the pharmacokinetics, pharmacodynamics and safety of single doses of camicinal in type 1 diabetes mellitus (T1DM) patients with a history of slow gastric emptying with symptoms consistent with gastroparesis. EXPERIMENTAL APPROACH In a randomized, double-blind, placebo-controlled, incomplete block, three-period, two-centre crossover study, patients received oral administration of placebo and two of the three possible doses of camicinal (25, 50 or 125 mg). Gastric emptying (C-13-octanoic acid breath test), pharmacokinetics and safety were primary outcomes. KEY RESULTS Nine of the 10 patients enrolled completed the study. Gastric half-emptying time decreased by -95 min (95% CI: -156.8, -34.2) after a single dose of camicinal 125 mg compared with placebo (52 vs. 147 min, P < 0.05), representing a 65% improvement. A decrease of the gastric half-emptying time compared with placebo (approximately 39 min) was observed with camicinal 25 and 50 mg, representing a 27% reduction for both doses (not statistically significant). A positive exposure-response relationship was demonstrated across all doses. The effects of camicinal on gastric half-emptying time were not influenced by fasting glucose levels. Single doses up to 125 mg were well tolerated. Camicinal was well absorbed, exhibiting linear and approximately dose-proportional pharmacokinetic characteristics and a clear exposure-response relationship with gastric emptying. CONCLUSIONS AND IMPLICATIONS Camicinal significantly accelerated gastric emptying of solids in T1DM patients following administration of a single oral dose. Camicinal was well tolerated and exhibited similar pharmacokinetic characteristics in diabetic patients to those previously reported in healthy volunteers.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
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