Table 4.
System organ class/MedDRA® preferred term | Treatment group |
|
---|---|---|
A, 15 minutes | B, 30 minutes | |
Number of subjects dosed | 35 | 34 |
Gastrointestinal disorders | ||
Vomiting | 0 | 1 (2.9%) |
Investigations | ||
Blood pressure increased | 1 (2.9%) | 0 |
Body temperature increased | 0 | 1 (2.9%) |
Nervous system disorders | ||
Headache | 2 (5.7%) | 1 (2.9%) |
SAEs | 0 | 0 |
Treatment (A): levothyroxine sodium 4 mL × 150 mcg/mL oral solution, 15 minutes before breakfast.
Treatment (B): levothyroxine sodium 4 mL × 150 mcg/mL oral solution, 30 minutes before breakfast.
MedDRA®, Medical Dictionary for Regulatory Activities, version 23.0; SAEs, significant adverse events.