Schematic representation of the study schedule

Time Relative to Dose Administration (H)	Vital Signs	Blood Sampling
-11.00	√
Before –10.00
-1.00 to 0.00	√	√
DOSING(00.00)
0.5		√
1.0		√
1.5		√
2.0		√
2.5		√
3.0		√
3.33		√
3.66		√
4.0	√	√
4.5		√
5.0		√
6.0	√	√
8.0		√
10.0		√
11.0	√
12.0		√
16.0		√
24.0	√	√
48.0 *	√	√
72.0**	√	√

√ Indicates study activities.
*Indicates samples will be collected on ambulatory basis.
**Medical examination will be done at the time of check in and at the end of the study (72.0 hr post dose sample of period III).

Table 2: Schematic representation of the study schedule for safety assessment and blood collection in period I/II/III.

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