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. Exclusion Criteria: * Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders * Has a history of severe drug allergy, or severe hypersensitivity or severe food allergy, including anaphylaxis or known allergy or sensitivity to any component of PGB or APAP * Has a history of alcoholism or drug abuse * Has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) at the time of Screening or Admission * Consumption of drugs with enzyme-inducing properties, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase * Has used any prescription medicines, over the counter medicines, or herbal supplements, within 7 days of dosing * Has used any investigational product or participated in any clinical trial within 30 days prior to Screening * Has donated or received any blood or blood products within the 3 months prior to Screening; * Not able to comply with the requirements of this study, including assessments, duration of admission of the study and expected follow up visits * Is unwilling or unable to give written informed consent