| |
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
|
