| The Pharmacokinetics, Acute Biological Effects and Safety of Recombinant Human Growth Hormones. |
|
Jong Jin Seo |
|
Department of pediatrics. College of Medicine, Chungnam National University, Taejeon, Korea |
| 유전자 재조합 인간 성장호르몬의 약물동태，
생물학적 효과 및 안전성에 관한 연구 |
|
서종진 |
|
충남대학교 의과대학 소아과학교실 |
|
Received: 6 February 1990 • Accepted: 3 May 1990 |
|
|
| Abstract |
|
The pharmacokinetics, acute biological성fccts and safety of yeast-derived recombinant methionyl-
hGH (LBD-003), the first biosynthetic hGH in Korea, were studied in 10 healthy young adults who
were administered 8 IU/day intramuscularly for four consecutive days.
1) GH levels reached a mean (±SD) peak of 27.5±10.7 ng/ml at 3.4±0.8 hours following the first
dose, and other pharmacokinetic parameters of LBD-003 were similar to those reported for
pituitary hGH and other biosynthetic hGH.
2) Markedly significant rise of IGF-1 and free fatty acid were observed after LBD-003 administra-
tion (p<0.0001), but fasting blood glucose and C-peptide concentrations were not changed signifi-
cantly.
3) There was no local or systemic untoward reactions during the 5 day period of observation
following the first dose of LBD-003.
4) No significant changes in hematologic features, urinalysis, acute phase reactants, indices of liver
and kidney function, and electrocardiography were noted following the administration of LBD-
003. Antibodies to hGH were not detected on days 30 or 60.
The results show that LBD-003 is safe in short term, well tolerated, has pharmacokinetic and
biological properties similar to pituitary hGH and other biosynthetic hGH. |
| Key Words:
Recombinant human growth hormone |
|
PDF Links
Download Citation
