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NCT01550926 Clinical Trial

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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01550926
Other study ID # W3680604
Secondary ID
Status Completed
Phase Phase 1
First received November 17, 2011
Last updated January 24, 2013
Start date February 2009
Est. completion date March 2009

Study information
Verified date April 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• 120 mg orlistat
2 X60 mg capsule
• 60 mg orlistat
60 mg orlistat
• orlistat experimental dose
experimental

Locations
Country Name City State
United Kingdom MDS Pharma Services Belfast N. Ireland

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fecal fat excretion 9 days No
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