A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules

March 27, 2017 updated by: Sandoz

A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions

The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C
  • No allergies to indomethacin or related drugs

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Indomethacin 75mg ER Capsules
Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz
ACTIVE_COMPARATOR: 2
Indocin 75mg SR Capsules
Drug: Indocin 75mg SR Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence according to US FDA guidelines.
Time Frame: 8 days
8 days

Collaborators and Investigators

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

Sponsor

Sandoz

Investigators

  • Principal Investigator: Anthony R Godfrey, Pharm. D., PRACS Institute, Ltd.

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

June 1, 2006

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (ESTIMATE)

March 9, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R06-0547

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.

Clinical Trials on Inflammation

Clinical Trials on Indomethacin 75mg Extended-Release Capsules, Sandoz

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe