Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
|Diabetes Mellitus, Non-Insulin-Dependent||Drug: Pramlintide acetate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
- 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).
|Study Start Date:||August 2002|
|Study Completion Date:||September 2002|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
Active Comparator: Pramlintide acetate (AC137)
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Drug: Pramlintide acetate
Clear, colorless, sterile solution for SC injection.
Placebo Comparator: Placebo
Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044707
|United States, Florida|
|Fort Lauderdale, Florida, United States, 33301|