| Trial ID: | L6210 |
| Source ID: | NCT00044707
|
| Associated Drug: |
Pramlintide Acetate
|
| Title: |
Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Non-Insulin-Dependent
|
| Interventions: |
DRUG: Pramlintide acetate
|
| Outcome Measures: |
Primary: 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, 7 Days | Secondary: 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)., 7 Days
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-08
|
| Completion Date: |
2002-09
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-21
|
| Locations: |
ICSL-Clinical Studies, Fort Lauderdale, Florida, 33301, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00044707
|
