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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and obese (Part B), otherwise healthy subjects.
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Inclusion and exclusion criteria
Inclusion Criteria:
Adult males or females aged 18 to 45 years inclusive;
Subjects with body mass index:
For Part A: ≥18 kg/m² and ≤25 kg/m²; For Part B: ≥33 kg/m² and ≤40 kg/m².
Subjects with a total body weight of ≥50 kg (Part A and Part B);
Subjects who are healthy as determined by the Investigator based on pre study medical history, physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and 12-lead ECG at screening and each admission;
Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;
Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;
Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;
Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or
≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;
Subjects who are able and willing to give written informed consent.
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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