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

Phase 1CompletedNCT00858195

Sandoz36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammation

Interventions

Indomethacin 75mg Extended-Release Capsules, SandozDRUG

Indocin 75mg SR CapsulesDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioequivalence according to US FDA guidelines.

Time frame: 8 days

Data from ClinicalTrials.gov

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