A Bioequivalence and Food Effect Study of Evacetrapib Evaluating a Single Tablet Compared to Two Tablets in Healthy Japanese Subjects

Eli Lilly Japan K.K.0 sitesStarted: October 9, 2014Last updated: October 17, 2023

Conditions

Trial Snapshot

No summary available.

•Overtly healthy Japanese, as determined by medical history and physical examination
•- Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2
•- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

•- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
•- Have an abnormal supine blood pressure as determined by the investigator
•- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
•- Are women who are pregnant or lactating
•- Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
•- Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
•- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
•- Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions

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