Pharmacokinetics and Bioequivalence of Two Combination Metformin/Glipizide Tablets under Fasting and Fed Conditions in Chinese Healthy Subjects: A Randomized, Open-Label, Crossover Study
Table 4
Summary of drug-related AEs.
AEs, n (%)
Fasting
Fed
All (N = 48)
Test (n = 23a)
Reference (n = 24)
Test (n = 23b)
Reference (n = 24)
Total AEs
7 (30.4)
13 (54.2)
10 (43.5)
11 (45.8)
41
AEs related to drugs
3 (13.0)
5 (20.8)
4 (17.4)
7 (29.2)
19
Hypoglycemia
1 (4.3)
2 (8.3)
2 (8.7)
1 (4.2)
6
Total bile acid increased
0
1 (4.2)
0
0
1
Acute pharyngitis
0
1 (4.2)
0
0
1
Head and neck pain
0
1 (4.2)
0
0
1
Dizziness
1 (4.3)
0
0
0
1
Hypertension
1 (4.3)
0
1 (4.3)
1 (4.2)
3
Diarrhea
0
0
1 (4.3)
3 (12.5)
4
Urine WBC count increased
0
0
0
1 (4.2)
1
Upper respiratory tract infection
0
0
0
1 (4.2)
1
AEs not related to drugs
4 (17.4)
8 (33.3)
6 (26.1)
4 (16.7)
22
Hypertriglyceridemia
1 (4.3)
3 (12.5)
1 (4.3)
0
5
Hypercholesterolemia
0
1 (4.2)
0
0
1
LDL increased
0
1 (4.2)
0
0
1
Hyperuricemia
1 (4.3)
1 (4.2)
1 (4.3)
0
3
Eosinophilia
1 (4.3)
0
1 (4.3)
0
2
ST-T change
0
1 (4.2)
0
0
1
Right lower limb soft tissue contusion
1 (4.3)
1 (4.2)
0
0
2
T-wave change
0
0
2 (8.7)
0
2
CK-MB increased
0
0
0
1 (4.2)
1
Urine occult blood
0
0
1 (4.3)
2 (8.3)
3
Neutropenia
0
0
0
1 (4.2)
1
At least grade three adverse reactions
0
0
0
0
0
SAE
0
0
0
0
0
Drug-related death
0
0
0
0
0
aOne subject withdrew from the period 2 without taking the test drug. bOne subject withdrew from the period 2 without taking the test drug.
