TABLE 4.

Adverse events after administration of test and reference formulations under fasted conditions.

	T Formulation (N = 18)		R Formulation (N = 18)		Total (N = 36)
	Case	Subjects [N (%)]	Case	Subjects [N (%)]	Case	Subjects [N (%)]
TEAEs	7	5 (13.89)	4	4 (11.11)	11	9 (25.00)
Various inspection	6	5 (13.89)	3	3 (8.33)	9	8 (22.22)
Elevated blood thyroid stimulating hormone	2	2 (5.56)	0	0 (0)	2	2 (5.56)
Elevated blood triglycerides	0	0 (0)	2	2 (5.56)	2	2 (5.56)
Neutrophil count decreased	2	2 (5.56)	0	0 (0)	2	2 (5.56)
Alanine aminotransferase was elevated	1	1 (2.78)	0	0 (0)	1	1 (2.78)
Hyperuricemia	1	1 (2.78)	0	0 (0)	1	1 (2.78)
Elevated free thyroxine	0	0 (0)	1	1 (2.78)	1	1 (2.78)
All kinds of neurological diseases	0	0 (0)	1	1 (2.78)	1	1 (2.78)
Giddy	0	0 (0)	1	1 (2.78)	1	1 (2.78)
Diseases of blood and lymphatic system	1	1 (2.78)	0	0 (0)	1	1 (2.78)
Anaemia	1	1 (2.78)	0	0 (0)	1	1 (2.78)

Abbreviation: TEAEs, treatment emergent adverse events; N, number of subjects; T, test formulation; R, reference formulation.