NCT01476215

Brief Summary

This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

November 24, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

November 3, 2011

Last Update Submit

November 20, 2014

Conditions

Healthy Subjects

Keywords

paracetamol

Outcome Measures

Primary Outcomes (1)

  • Time to plasma level above therapeutic level

    baseline to 8 hours

Secondary Outcomes (1)

  • General PK parameters (e.g. AUC, Tmax, Cmax)

    baseline to 8 hours

Study Arms (4)

Fast dissolution suspension

EXPERIMENTAL
Drug: Paracetamol fast dissolution suspension

Medium dissolution suspension

EXPERIMENTAL
Drug: Paracetamol medium dissolution suspension

Slow dissolution suspension

EXPERIMENTAL
Drug: Paracetamol slow dissolution suspension

Marketed suspension

ACTIVE COMPARATOR
Drug: Paracetamol

Interventions

Paracetamol fast dissolution suspensionDRUG
Fast dissolution suspension
Paracetamol medium dissolution suspensionDRUG
Medium dissolution suspension
Paracetamol slow dissolution suspensionDRUG
Slow dissolution suspension
ParacetamolDRUG
Marketed suspension

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer
  • Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, 68501, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 22, 2011

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 24, 2014

Record last verified: 2014-06

Locations

US(1)