A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

January 24, 2013 updated by: GlaxoSmithKline
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • N. Ireland
      • Belfast, N. Ireland, United Kingdom, BT9 6AD
        • MDS Pharma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age: 18-60 years
  • Body Mass Index: 25-33

Exclusion Criteria:

  • gastrointestinal disease
  • organ transplant
  • HIV, hepatitis B or C
  • food allergies
  • alcohol or other substance abuse
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
60 mg orlistat
Drug: 60 mg orlistat
60 mg orlistat
Active Comparator: Arm 2
120 mg orlistat (2 X 60 mg capsules)
Drug: 120 mg orlistat
2 X60 mg capsule
Experimental: Arm 3
orlistat experimental formulation
Drug: orlistat experimental dose
experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal fat excretion
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W3680604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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