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Table 2 Schedule of Assessments for both Stage 1 and 2

From: Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product

 

Pre-Trial

Period 1

Wash- Out

Period 2

Wash-Out

Period 3

End of Study

Days

-28 to 0

0

1

2

1–7

7

8

9

8–14

14

15

16

16

Informed Consent Form Signed

X

            

Admission to Unit

 

X

   

X

   

X

   

Medical History

X

            

Physical Examination

X

           

X

Laboratory Tests

X

X

   

X

   

X

  

X

HIV Ag/Ac Combo, HBsAg (B) (Hepatitis B) and anti-HCV (C) Tests

X

            

Urine Alcohol and Drugs of Abuse Screening

X

X

   

X

   

X

   

ECG

X

           

X

Pregnancy Test

X

X

   

X

   

X

  

X

Vital Signs

X

 

X

   

X

   

X

 

X

Neurological Function Test

X

  

X

   

X

   

X

 

Drug Administration

  

X

   

X

   

X

  

Blood Sampling

  

X

X

  

X

X

  

X

X

 

Adverse Event Monitoring

  

X

X

X

X

X

X

X

X

X

X

X