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Submitted on August 5, 2004
Accepted on February 7, 2005
Department of Clinical Pharmacology and Kinetics, Organon, Oss, the Netherlands; International Regulatory Affairs, Organon, Oss, the Netherlands; Xendo Laboratories, Groningen, the Netherlands;Focus Clinical Drug Development, Neuss, Germany; International Medical Services, Organon, Oss, the Netherlands
* To whom correspondence should be addressed. E-mail: wilma.bagchus{at}organon.com.
Pharmacokinetics of nandrolone in serum and urine was investigated in healthy young men after a single intramuscular injection of 50 mg (n = 20), 100 mg (n = 17) or 150 mg (n = 17) nandrolone decanoate. Blood samples were collected pre-dose and for up to 32 days after dosing. In addition, in the 50 and 150 mg groups 24-hours urine samples were collected at pre-dose and during days 1, 7 and 33, and in the 150 mg group additional samples were collected after 3 and 6 months. Serum concentrations and area-under-curve of nandrolone increased proportionally with the dose administered. Peak serum concentration (Cmax) ranged from 2.14 ng/mL in the 50 mg group to 4.26 ng/mL in the 100 mg group and to 5.16 ng/mL in the 150 mg group. Cmax was reached after 30 (50 and 100 mg) and 72 h (150 mg), whereas the terminal half-life was 7-12 days. In urine, pre-dose concentrations of 19-NA and/or 19-NE were detected in 5/37 subjects (14%). In the 50 mg group, 19-NA and/or 19-NE could be detected at least until 33 days after injection in 16/17 subjects (94%). In the 150 mg group of subjects presumed to have not previously used nandrolone, nandrolone metabolites could be detected up to 6 months in 8/12 subjects (67%) for 19-NE to 10/12 subjects (83%) for 19-NA.
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