Table 1.

Procedures of the phase 1 clinical trial.

Procedures	Visits
	0	1. Screeninga	2. Day 1 of first entryb	3. Day 2 of first entryc	4. Day 3 of first entryd	5. Day 4 of first entrye	6. Day 4 of first entryf	Washoutg	7. Day 1 of second entryh	8. Day 2 of second entryi	9. Day 3 of second entryj	10. Day 4 of first entryk	11. Day 4 of first entryl
Informed consent	✓	—m	For the phase 4 trial	—	—	—	—	—	—	—	—	—	—
Inclusion and exclusion	✓	✓	✓	✓	—	—	—	—	—	—	✓	✓	—
Concomitant medications	—	✓	✓	✓	✓	✓	✓	—	✓	✓	✓	✓	✓
Blood and urine analysis	—	✓	—	—	—	—	—	—	—	—	—	—	—
Medical history	—	✓	—	—	—	—	—	—	—	—	—	—	—
Physical examination	—	✓	—	✓	—	—	—	—	—	✓	—	—	—
Height	—	✓	—	—	—	—	—	—	—	—	—	—	—
Weight	—	✓	—	✓	—	—	—	—	—	✓	—	—	—
Electrocardiogram	—	✓	—	✓	—	—	—	—	—	✓	—	—	—
Vital signs (HRn, BPo)	—	✓	—	✓	—	—	—	—	—	✓	—	—	—
Tympanic temperature	—	✓	—	✓	—	—	—	—	—	✓	—	—	—
Peripheral vein catheterization	—	—	—	✓	—	—	—	—	—	✓	—	—	—
Pharmacokinetic blood basal sample	—	—	—	✓	—	—	—	—	—	✓	—	—	—
Drug administration	—	—	—	✓	—	—	—	—	—	✓	—	—	—
Pharmacokinetic blood samples	—	—	—	✓	✓	✓	✓	—	—	✓	✓	✓	✓
Venepuncture	—	—	—	—	✓	✓	✓	—	—	—	✓	✓	✓
Adverse events record	—	—	✓	✓	✓	✓	✓	—	✓	✓	✓	✓	✓

^aUp to 3 days after visit 0.

^b1 week after screening.

^c10 hours after visit 2.

^d24 hours after visit 3.

^e48 hours after visit 4.

^f72 hours after visit 5.

^g1 week after visit 6.

^hUp to 24 hours after washout.

ⁱ10 hours after visit 7.

^j24 hours after visit 8.

^k48 hours after visit 9.

^l72 hours after visit 10.

^mNot applicable.

ⁿHR: heart rate.

^oBP: blood pressure.