Lead Sponsor

Manjunath Prakash Pai

Collaborators

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

•Subjects fulfilling the following criteria will be eligible:
•1. males and females, 18 to 50 years of age;
•2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
•3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
•4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

•1. history of significant hypersensitivity reaction to any components of Tygacil®;
•2. history of significant clinical illness requiring pharmacological management;
•3. history of blood donation in the past eight week period;
•4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;
•5. transaminases (AST or ALT) \> 2.5 x upper limit of normal;
•6. subjects with stage 4 or 5 chronic kidney disease;
•7. positive serum pregnancy test (if female);
•8. abnormal electrocardiogram (ECG) as judged by study physician;
•9. unable to tolerate venipuncture and multiple blood draws;
•10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
•11. unable to independently provide a written informed consent.

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