A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers

Inclusion Criteria

• •Male or female aged 18 to 55 years, inclusive at time of Screening
• •Body mass index (BMI) between 18.5 and 28.0 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg
• •Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG confirming normal sinus rhythm
• •Negative tests for Hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening
• •Routine clinical laboratory tests should be within normal limits at Screening and Admission (Day -1) or abnormalities deemed not clinically significant by the Investigator; for liver function tests, AST and ALT values should not be greater than 1.5 times the upper limit of normal range
• •Negative screen for drugs of abuse or exhibit detectable alcohol levels by breathalyzer at the time of Screening or Admission
• •Non-smokers or ex-smokers (must have ceased smoking ≥3 months prior Screening visit)
• •Female subjects:
• •Must be of non-childbearing potential by surgical sterilization or postmenopausal OR Must not be pregnant, breast feeding, or planning to become pregnant AND must be practicing both a highly effective method of birth control from Screening until at least 90 days after the last dose of study drug.
• •Women of childbearing potential must have a negative pregnancy test result at Screening and upon admission to the Clinical Trial Unit.