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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  10/24/2008
 
Trade Name:  Apidra
 
Generic or Proper Name (*):  insulin glulisine recombinant
 
Indications Studied:  Diabetes Mellitus
 
Therapeutic Category:  Antidiabetic
 
Ages Studied:  4-17 years
 
Study #:  2
 
Study Type:  Safety/Pharmacokinetic/Pharmacodynamic
 
Study Design:  Single-Blind/Traditional Pharmacokinetic/Crossover
 
No Patients:  20
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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