Linked Life Data

8884873

Source:http://linkedlifedata.com/resource/pubmed/id/8884873

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
1997-2-19
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 Conventional growth hormone-therapy was withdrawn 2 days before each study period.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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
0901-9928
pubmed:author
pubmed:issnType
Print
pubmed:volume
79
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
144-9
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed-meshheading:8884873-Absorption, pubmed-meshheading:8884873-Adult, pubmed-meshheading:8884873-Benzyl Alcohol, pubmed-meshheading:8884873-Benzyl Alcohols, pubmed-meshheading:8884873-Biological Availability, pubmed-meshheading:8884873-Blood Glucose, pubmed-meshheading:8884873-Buffers, pubmed-meshheading:8884873-Cross-Over Studies, pubmed-meshheading:8884873-Denmark, pubmed-meshheading:8884873-Female, pubmed-meshheading:8884873-Human Growth Hormone, pubmed-meshheading:8884873-Humans, pubmed-meshheading:8884873-Injections, Subcutaneous, pubmed-meshheading:8884873-Insulin-Like Growth Factor I, pubmed-meshheading:8884873-Male, pubmed-meshheading:8884873-Middle Aged, pubmed-meshheading:8884873-Radioimmunoassay, pubmed-meshheading:8884873-Recombinant Proteins, pubmed-meshheading:8884873-Single-Blind Method
pubmed:year
1996
pubmed:articleTitle
Bioavailability of recombinant human growth hormone in different concentrations and formulations.
pubmed:affiliation
Medical Department M (Endocrinology and Diabetes), Aarhus Kommunehospital, Aarhus University, Denmark.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial