This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
84
Natural fruit extract consumed with rice
Assumed key active consumed with rice
Rice only
Charité Research Organisation GmbH
Berlin, Germany
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
+iAUC
Time frame: 0-2 hours
Change of 3-h PPG based on response to different treatments
+iAUC
Time frame: 0-3 hours
Change of 2-h and 3-h post-prandial insulin based on response to different treatments
tAUC
Time frame: 0-2 hours and 0-3 hours
Max plasma concentration for assumed key active
Cmax
Time frame: 0-12 hours
Time of max plasma concentration for assumed key active
Tmax
Time frame: 0-12 hours
AUC for plasma concentration versus time curve for assumed key active
AUC
Time frame: 0-12 hours
Half-life of elimination phase for assumed key active
t1/2
Time frame: 0-12 hours
Total amount of assumed key active excreted in urine
Time frame: 0-36 hours
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