Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-335

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839293

M10-788

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A condition of general good health
• BMI 18 to 29

Exclusion criteria

• Currently enrolled in another clinical study
• Females who are pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

A

Experimental group

Description:

ABT -335 capsules 135mg

Treatment:

Drug: ABT-335

B

Experimental group

Description:

ABT-335 capsules 45mg

Treatment:

Drug: ABT-335