NCT00858195

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1

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

June 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 5, 2009

Last Update Submit

March 27, 2017

Conditions

Inflammation

Keywords

Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines.

    8 days

Study Arms (2)

1

EXPERIMENTAL

Indomethacin 75mg ER Capsules

Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz

2

ACTIVE COMPARATOR

Indocin 75mg SR Capsules

Drug: Indocin 75mg SR Capsules

Interventions

Indomethacin 75mg Extended-Release Capsules, SandozDRUG
1
Indocin 75mg SR CapsulesDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anthony R Godfrey, Pharm. D.

    PRACS Institute, LTD.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

June 1, 2006

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 29, 2017

Record last verified: 2009-03