Pharmacokinetics of octreotide acetate long acting release (OALAR) in volunteers

L. B. Anthony, L. Petryk, J. Olejarczyk, E. C. Foulds, H. F. Schran

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

To develop a long acting formulation of octreotide (Sandostatin®), a double-blind placebo controlled trial of single IM doses of OALAR was performed in 48 subjects (males=11). Serum was collected, octreotide levels measured using RIA and pharmacokinetic analyses performed as follows: means (+/- S.E.) Dose Tmax Cmax>24 hr AUC(0-44D) (mg) (hr) (pg/ml) (pg × hr/ml) 1.5 544 (104) 40 (27) 19,462 (6,224) 3.0 632 (197) 315 (280) 54,481(16,937) 6.0 437 (169) 230 (97) 108,548 (14,129) 12 452 (177) 1,097 (268) 385,735 (20,550) 20 656 (91) 1,457 (142) 818,711 (56,124) 30 532 (107) 2,812 (209) 1.42 E 6(2.89 E 5) AUC and Cmax>24 hr correlated to dose and could be described by a simple linear model. Sustained serum levels for 37-76 days occurred with the 2 higher doses and decreased 55 days post injection with serum levels detectable up to 100 days. Assuming a minimal effective level of 1 ng/ml, the 30 mg dose could provide therapeutic hormonal suppression from 9 to 45 days.

Original languageEnglish
Pages (from-to)144
Number of pages1
JournalClinical Pharmacology and Therapeutics
Volume61
Issue number2
StatePublished - 1997

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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