Current partner codePEPTIDESDE
NCT00044707·Phase 2·INTERVENTIONAL

Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

Status

Completed

Phase

Phase 2

Enrollment

24

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Pramlintide acetate

Clear, colorless, sterile solution for SC injection.

Timeline

From registration to results.

  1. First posted

    Sep 5, 2002

  2. Study start

    Aug 2002

  3. Primary completion

    Sep 2002

  4. Study completion

    Sep 2002

  5. Results posted

    Not reported

  6. Registry updated

    May 21, 2015

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Type 2 diabetes mellitus treated with diet and/or oral agents * HbA1c 6.5-11.0

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ICSL-Clinical Studies

Fort Lauderdale, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.