DRUG
Pramlintide acetate
Clear, colorless, sterile solution for SC injection.
Status
Completed
Phase
Phase 2
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study summary
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
Interventions
DRUG
Clear, colorless, sterile solution for SC injection.
Timeline
First posted
Sep 5, 2002
Study start
Aug 2002
Primary completion
Sep 2002
Study completion
Sep 2002
Results posted
Not reported
Registry updated
May 21, 2015
Outcomes
To determine the effect of pramlintide on the PK of an oral medication
Time frame · 7 Days
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
safety and tolerability as measured by analysis of laboratory values and adverse events
Time frame · 7 Days
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).
Eligibility
Inclusion Criteria: * Type 2 diabetes mellitus treated with diet and/or oral agents * HbA1c 6.5-11.0
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ICSL-Clinical Studies
Fort Lauderdale, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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