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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858195

Enrollment

Registered

2009-03-09

Start date

2006-06-30

Completion date

2006-07-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Anti-inflammatory

Brief summary

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

Interventions

DRUGIndomethacin 75mg Extended-Release Capsules, Sandoz

DRUGIndocin 75mg SR Capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence according to US FDA guidelines.	8 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026