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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Inflammation

Treatments: Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz; Drug: Indocin 75mg SR Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858195

R06-0547

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

Indomethacin 75mg ER Capsules

Treatment:

Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz

2

Active Comparator group

Description:

Indocin 75mg SR Capsules

Treatment:

Drug: Indocin 75mg SR Capsules