Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa: Design 3+3 Phase I Clinical Trial

Table 1

Safety assessments: kidney, hepatic, electrolyte, metabolic, and hematological parameters.

	Extract P2Et 600 mg/d
	Baseline visit	End visit	% Change
	(n = 7)	(n = 7)
Urea nitrogen blood (mg/dL)	13.7 [11.1, 20.4]	13.0 [9.10, 23.7]	2.36 [−20.2, 73.0]
Serum creatinine (mg/dL)	0.870 [0.630, 1.09]	0.860 [0.650, 1.14]	−1.15 [−9.09, 10.7]
AST (U/L)	20.0 [12.0, 22.0]	22.0 [13.0, 50.0]	8.33 [−11.1, 127]
ALT (U/L)	19.0 [14.0, 23.0]	21.0 [14.0, 44.0]	13.3 [−21.1, 214]
Total bilirubin (mg/dL)	0.690 [0.470, 1.08]	0.660 [0.420, 0.920]	−8.33 [−28.6, 58.6]
Sodium (mmol/L)	139 [136, 141]	138 [136, 141]	0.00 [−2.16, 0.735]
Potassium (mmol/L)	4.40 [4.00, 4.80]	4.50 [4.00, 5.00]	0.00 [−6.98, 12.5]
Calcium (mg/dL)	9.50 [9.10, 9.70]	9.50 [9.00, 9.70]	0.00 [−5.26, 4.40]
Magnesium (mg/dL)	2.00 [1.80, 2.10]	2.00 [1.80, 2.10]	0.00 [−5.26, 11.1]
Plasma glucose (mg/dl)	84.0 [78.0, 99.0]	88.0 [78.0, 96.0]	1.18 [−3.03, 4.76]
Total cholesterol (mg/dl)	170 [122, 250]	178 [98.7, 226]	−3.47 [−19.4, 4.66]
Triglycerides (mg/dl)	69.7 [47.7, 147]	70.2 [40.4, 161]	−6.33 [−48.7, 84.9]
Sht (Uu/mL)	1.24 [0.690, 3.42]	1.44 [0.630, 2.09]	−8.70 [−38.9, 55.6]
C-reactive protein (mg/dl)	0.100 [0.03, 0.50]	0.180 [0.05, 2.17]	133 [−64.0, 570]
Lactate dehydrogenase (U/L)	159 [130, 174]	161 [128, 210]	3.12 [−4.47, 31.8]
Hemoglobin (g/dl)	14.7 [13.6, 17.9]	14.5 [14.1, 16.7]	0.621 [−6.70, 6.62]
Hematocrit (%)	43.0 [40.4, 51.0]	43.1 [41.0, 47.9]	1.05 [−7.06, 5.12]
Medium corpuscular volume (fL)	89.0 [87.1, 97.2]	88.3 [87.4, 98.2]	0.344 [−2.97, 1.03]
Mean corpuscular hemoglobin (pg)	30.5 [29.6, 33.3]	30.6 [29.7, 33.8]	0.338 [−1.98, 1.50]
Mean corpuscular hemoglobin concentration (g/dl)	34.0 [33.5, 35.1]	34.1 [33.1, 35.2]	0.285 [−2.93, 2.67]
MPV (fL)	7.10 [6.90, 9.20]	7.50 [6.70, 9.00]	1.35 [−3.80, 7.04]
Erythrocyte sedimentation rate (mm/h)	2.00 [2.00, 10.0]	5.00 [2.00, 16.0]	0.00 [−50.0, 700]

Data are in median [minimum, maximum] range; (n = 7). AST, aspartate aminotransferase; ALT, alanine aminotransferase; SHT, stimulating hormone thyroid; MPV, medium platelet volume.