This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Clear, colorless, sterile solution for SC injection.
ICSL-Clinical Studies
Fort Lauderdale, Florida, United States
To determine the effect of pramlintide on the PK of an oral medication
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax. t½: Terminal half-life The primary study endpoints include: * pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints * pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
Time frame: 7 Days
safety and tolerability as measured by analysis of laboratory values and adverse events
To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).
Time frame: 7 Days
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