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Table 1 Summary of fourteen 4-product, 4-sequence, 4-period, sequence-randomized, crossover bioequivalence studies on 14 immediate-release, non-combinational, oral drugs

From: Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs

Drug Participants,
no., sex
Age,
mean (SD),
year
BMI,
mean (SD),
kg/m2
Washout period,
day
Sampling frame,
hour
Withdrawals, no. (no. missed periods, reason) Possible product
failurea, no.
(product, period)
Adverse events (no.)b Assay
(lower quantification limit)
Amlodipine
10 mg
54 M
2 F
34.0 (7.2) 24.3 (3.0) 14 240 1 (1, venous access)
1(4, personal)
1 (reference, 3rd) Headache (1)
Drowsiness (1)
LC-MS
(0.20 ng/ml)
Amoxicillin
500
52 M 31.2 (4.5) 24.2 (2.8) 3–7 10 3 (3, personal) None Dizziness (1) HPLC
(0.50 μg/ml)
Atenolol
100 mg
52 M 30.5 (5.0) 23.0 (2.3) 7 36 2 (3, Flu-like symptoms)
2 (4, personal)
None Flu-like symptoms (2)
Vomiting (1)
HPLC
(0.01 μg/ml
Cephalexin
500 mg
36 M 32.3 (7.3) 24.5 (5.0) 2–7 6 4 (3, personal) None Headache (1) HPLC
(0.50 μg/ml)
Ciprofloxacin
500 mg
44 M 34.6 (6.5) 26.1 (3.7) 7 24 1 (2, personal)
1 (3, skin rash)
1 (4, high BP)
None Skin rash (1) HPLC
(0.10 μg/ml)
Clarithromycin
500 mg
48 M 30.8 (5.0) 23.5 (2.6) 7 24 1 (1, venous access) None Headache (1)
Stomach upset (1)
LC-MS
(5.0 ng/ml)
Diclofenac
50 mg
72 M 30.9 (5.4) 24.0 (3.0) 2–7 6 2 (1, personal)
1 (1, incompliance)
2 (3, personal)
None Dizziness (1)
Cough (1)
HPLC
(0.02 μg/ml)
Ibuprofen
400 mg
30 M
2 F
34.6 (9.0) 25.6 (3.3) 7 10 1 (1, personal)
1 (2, personal)
4 (3, personal)
1 (reference, 2nd) Near fainting (1) HPLC
(0.25 μg/ml)
Fluconazole
150 mg
28 M 36.9 (8.7) 24.4 (3.0) 14 168 1 (2, skin rash)
2 (4, personal)
None Skin rash (1)
Headache (1)
HPLC
(0.20 μg/ml)
Metformin
850 mg
52 M 31.9 (5.8) 23.9 (2.6) 7 32 1 (1, personal)
1 (2, personal)
1 (3, personal)
1 (4, personal)
None Diarrhea (1)
Headache (1)
HPLC
(0.05 μg/ml)
Metronidazole
250 mg
28 M 31.8 (5.6) 24.3 (2.8) 7 48 None 1 (generic b, 1st) Headache (2) HPLC
(0.05 μg/ml)
Omeprazole
20 mg
80 M 31.8 (5.0) 24.8 (3.5) 7 12 1 (1, personal)
1 (2, personal)
3 (3, personal)
1 (4, incompliance)
1 (4, high BP)
None Dizziness (2) HPLC
(0.01 μg/ml)
Paracetamol
500 mg
44 M 32.3 (6.2) 24.1 (3.6) 2–7 14 1 (2, personal)
3 (3, personal)
1 (4, incompliance)
1 (generic b, 2nd) None HPLC
(0.10 μg/ml)
Ranitidine
150 mg
74 M
2 F
31.8 (5.5) 25.2 (3.2) 2–7 14 1 (1, personal)
1 (2, venous access)
1 (3, venous access)
1 (3, incompliance)
1 (3, vomiting)
1 (4, venous access)
None Vomiting (2)
Diarrhea (2)
Dizziness (1)
HPLC
(0.03 μg/ml)
  1. Eighteen blood samples were obtained during each period of each study
  2. aThe study could not distinguish product failure from failure to take the drug
  3. bAll adverse events were minor and resolved spontaneously. HPLC High performance liquid chromatography, LC-MS Liquid chromatography-mass spectrometry, BP Blood pressure. Flu-like, influenza-like