| pubmed-article:8884873 | rdf:type | pubmed:Citation | lld:pubmed |
| pubmed-article:8884873 | lifeskim:mentions | umls-concept:C0086045 | lld:lifeskim |
| pubmed-article:8884873 | lifeskim:mentions | umls-concept:C0005508 | lld:lifeskim |
| pubmed-article:8884873 | lifeskim:mentions | umls-concept:C0524527 | lld:lifeskim |
| pubmed-article:8884873 | lifeskim:mentions | umls-concept:C0384570 | lld:lifeskim |
| pubmed-article:8884873 | pubmed:issue | 3 | lld:pubmed |
| pubmed-article:8884873 | pubmed:dateCreated | 1997-2-19 | lld:pubmed |
| pubmed-article:8884873 | pubmed:abstractText | Whether the bioavailability of growth hormone depends on the concentration or formulation of the preparation was evaluated in 18 growth hormone-deficient patients. The design was a single-blinded, randomized cross-over study, where the patients were given a single, fixed dose subcutaneous injection of growth homrone (3 IU/m2) of 3 different preparations: (1) 4 IU/ml in a bicarbonate buffer dissolved in 0.9% benzyl alcohol (approximately 1.37 mg/ml), (2) 5.9 IU/ml in a phosphate buffer dissolved in 1.5% benzyl alcohol (approximately 2 mg/ml) and (3) 11 7 IU/ml in a phosphate buffer dissolved in 1.5% benzyl alcohol (approximately 4 mg/ml). Conventional growth hormone-therapy was withdrawn 2 days before each study period. Blood samples were drawn over a 24-hr period and assessed for growth hormone, serum insulin-like growth factor I (IGF-I), insulin and glucose. The geometric mean values (+/- geometric S.D) of the relative absorption fractions were F5.9 IU/4 IU = AUC5.9 IU/AUC4 IU = (+/- 1.139) (P = 0.66), F11.7 IU/AUC4 IU = AUC11.7 IU/AUC4 IU (1.14 +/- 1.21) (P = 0.009) AND F11.7 IU/5.9 IU = AUC11.7 IU/AUC5.9 IU = 1.12 (+/- 1.17) (P = 0.005), respectively. The 90% confidence intervals were contained within the limits of 0.80-1.25 accepted for bioequivalence. Geometric mean values (+/- geometric S.D.) of the relative observed maximum concentration, Cmax was for Cmax 5.9 IU/Cmax 4 IU = 1.04 (+/- 1.19) (P = 0.32), Cmax 11.7 IU/Cmax 4 IU = 1.24 (+/- 1.21) (P = 0.0002) and Cmax 11.7 IU/Cmax 5.9 IU = 1.19 (+/- 1.29) (P = 0.012). The median and the range values for the observed time to reach Cmax was tmax 5.9 IU/tmax 4 IU = 0.63 (0.04-1.00), tmax 11.7 IU/tmax 4 IU = 0.59 (0.06-1.0) and tmax 11.7 IU/tmax 5.9 IU = 0.90 (0.51-18.00). There were no significant differences in IGF-I, glucose and insulin profiles. Based on the upper limits of the 90% confidence intervals for relative AUC's the conclusion is that the three different preparations were bioequivalent. | lld:pubmed |
| pubmed-article:8884873 | pubmed:language | eng | lld:pubmed |
| pubmed-article:8884873 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:citationSubset | IM | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:8884873 | pubmed:status | MEDLINE | lld:pubmed |
| pubmed-article:8884873 | pubmed:month | Sep | lld:pubmed |
| pubmed-article:8884873 | pubmed:issn | 0901-9928 | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:ChristiansenJ... | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:JensenS BSB | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:HilstedJJ | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:JørgensenJ... | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:SusgaardSS | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:RasmussenU... | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:VahsWW | lld:pubmed |
| pubmed-article:8884873 | pubmed:author | pubmed-author:RasmussenM... | lld:pubmed |
| pubmed-article:8884873 | pubmed:issnType | Print | lld:pubmed |
| pubmed-article:8884873 | pubmed:volume | 79 | lld:pubmed |
| pubmed-article:8884873 | pubmed:owner | NLM | lld:pubmed |
| pubmed-article:8884873 | pubmed:authorsComplete | Y | lld:pubmed |
| pubmed-article:8884873 | pubmed:pagination | 144-9 | lld:pubmed |
| pubmed-article:8884873 | pubmed:dateRevised | 2004-11-17 | lld:pubmed |
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| pubmed-article:8884873 | pubmed:meshHeading | pubmed-meshheading:8884873-... | lld:pubmed |
| pubmed-article:8884873 | pubmed:year | 1996 | lld:pubmed |
| pubmed-article:8884873 | pubmed:articleTitle | Bioavailability of recombinant human growth hormone in different concentrations and formulations. | lld:pubmed |
| pubmed-article:8884873 | pubmed:affiliation | Medical Department M (Endocrinology and Diabetes), Aarhus Kommunehospital, Aarhus University, Denmark. | lld:pubmed |
| pubmed-article:8884873 | pubmed:publicationType | Journal Article | lld:pubmed |
| pubmed-article:8884873 | pubmed:publicationType | Clinical Trial | lld:pubmed |
| pubmed-article:8884873 | pubmed:publicationType | Randomized Controlled Trial | lld:pubmed |
| http://linkedlifedata.com/r... | pubmed:referesTo | pubmed-article:8884873 | lld:pubmed |
