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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  10/05/2010
 
Trade Name:  Aridol Powder for Inhalation
 
Generic or Proper Name (*):  mannitol
 
Indications Studied:  Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma
 
Therapeutic Category:  Diagnostic aid
 
Ages Studied:  6-17 years
 
Study #:  3
 
Study Type:  Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  23
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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