Document Detail


Relative bioavailability of salmon calcitonin given intramuscularly.
MedLine Citation:
PMID:  10969448     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Salmon calcitonin, a polypeptide hormone, is used in the treatment of osteoporosis, hypercalcemia and Paget's disease. The purpose of this study was to evaluate the pharmacokinetics and relative bioavailability of two salmon calcitonin products, Miacalcic (Novartis Pharmaceuticals, Basle, Switzerland) and Calcinin (Purzer Pharmaceuticals, Taipei, Taiwan). METHODS: This was a randomized, single-dose, crossover study conducted under fasting conditions with a washout period of 1 week between doses. Ten healthy male subjects were enrolled in this study. Each subject received a 100 IU dose (20 micrograms; 50 IU/ampule x 2) of salmon calcitonin intramuscularly (i.m.) followed by collection of blood samples at specified time intervals. Serum salmon calcitonin concentrations were measured using a validated radioimmunoassay method with a detection limit of 15.0 pg/ml. Values for the area under the serum concentration from time zero to last time and infinity curve (AUC0-t and AUC0-infinity), peak concentration (Cmax), time to peak concentration, terminal first order rate constant, terminal half-life, mean residence time, total clearance divided by absolute bioavailability, onset time, maximal effect and duration were compared for each product. RESULTS: The 90% confidence intervals for AUC0-t, AUC0-infinity and Cmax after logarithmic transformation were 93.2% to 113.1%, 97.2% to 114.9% and 84.9% to 108.0%, respectively. CONCLUSIONS: Based on the two one-sided tests procedure, we conclude that Miacalcic and Calcinin are bioequivalent.
Authors:
P Chen; J M Lai; J F Deng; S B Lu; H Ku
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Zhonghua yi xue za zhi = Chinese medical journal; Free China ed     Volume:  63     ISSN:  0578-1337     ISO Abbreviation:  Zhonghua Yi Xue Za Zhi (Taipei)     Publication Date:  2000 Aug 
Date Detail:
Created Date:  2000-09-14     Completed Date:  2000-09-14     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0005327     Medline TA:  Zhonghua Yi Xue Za Zhi (Taipei)     Country:  CHINA    
Other Details:
Languages:  eng     Pagination:  619-27     Citation Subset:  IM    
Affiliation:
Pharmaceutical R & D Laboratories, Development Center for Biotechnology, Taipei, Taiwan, ROC.
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MeSH Terms
Descriptor/Qualifier:
Adult
Biological Availability
Calcitonin / administration & dosage,  pharmacokinetics*
Calcium / blood
Cross-Over Studies
Double-Blind Method
Humans
Injections, Intravenous
Male
Therapeutic Equivalency
Chemical
Reg. No./Substance:
47931-85-1/salmon calcitonin; 7440-70-2/Calcium; 9007-12-9/Calcitonin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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