Safety, Tolerability and Pharmacokinetic Study of Recombinant Human Parathyroid Hormone [rhPTH （1-84）] in Chinese Healthy Volunteers

The current study was designed to determine the safety, tolerability and pharmacokinetic parameters of recombinant human parathyroid hormone [rhPTH （1-84）] used for the treatment of osteoporosis. In the single-dose format pharmacokinetic study, thirty-six healthy male volunteers received three dose...

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Bibliographic Details
Published in:	Journal of Huazhong University of Science and Technology. Medical sciences Vol. 29; no. 4; pp. 431 - 434
Main Author:	李茜乔建邓俊刚曾天舒周丕琪黎维勇
Format:	Journal Article
Language:	English
Published:	Heidelberg Huazhong University of Science and Technology 01-08-2009 Institute of Clinical Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
Subjects:	Adult China Humans Male Medicine Medicine & Public Health Parathyroid Hormone - adverse effects Parathyroid Hormone - blood Parathyroid Hormone - pharmacokinetics Recombinant Proteins - adverse effects Recombinant Proteins - blood Recombinant Proteins - pharmacokinetics Young Adult 人甲状旁腺激素安全性志愿者药物耐受性酶联免疫吸附试验 China pharmacokinetics recombinant human parathyroid hormones safety tolerability
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Summary:	The current study was designed to determine the safety, tolerability and pharmacokinetic parameters of recombinant human parathyroid hormone [rhPTH （1-84）] used for the treatment of osteoporosis. In the single-dose format pharmacokinetic study, thirty-six healthy male volunteers received three dose levels of rhPTH （1-84） subcutaneously： 1, 2, and 4 μg/kg. The blood was timing drawn and the serum concentration of rhPTH （1-84） was determined by enzyme linked immunosorbent assay （ELISA）. Serum concentration-time curves of PTH （1-84） exhibited a double-peak pattern, the first peak appearing about 10 to 30 min after administration and the second peak occurring about 1.5 to2 h after administration. Serum terminal half-time of PTH （1-84） was approximately 2 h. The parameters indicated the serum levels were directly proportional to the administered dose, with the mean Cmax and AUC0_24 ranging from approximately 543.47 to 1845 pg/mL and 2358.6 to 9232.12 pg.h.mL^-1 over the dose range. The drug was well tolerated, the clinical symptoms were generally mild and of short duration.
Bibliography:	safety; tolerability; pharmacokineties; recombinant human parathyroid hormones 42-1679/R recombinant human parathyroid hormones Q573 safety tolerability pharmacokineties S884.51
ISSN:	1672-0733 1993-1352
DOI:	10.1007/s11596-009-0408-6