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 |