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A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Subjects - NCT01157104-68502(Clinical Trial 688159)



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City:  Lincoln
State:  
NE
Zip Code: 68502
Conditions: Chronic Hepatitis C
Purpose: This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy subjects.
Study summary:
Criteria: Inclusion Criteria: To participate in the study, subjects must meet the following requirements: 1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2. 2. Must be a non-smoker. 3. Must agree to use an acceptable double-barrier method of birth control. 4. Must provide written informed consent after the study has been fully explained. Exclusion Criteria: Subjects are not eligible if they meet any of the following: 1. Pregnant or breastfeeding. 2. History of clinically significant diseases, as determined by the investigator. 3. Safety laboratory abnormalities at screening which are clinically significant. 4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). 5. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study. 6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
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Data Source: ClinicalTrials.gov
Date Processed: November 28, 2010
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