Skip to main content

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
Back to article page

BMC Pharmacology and Toxicology

ISSN: 2050-6511

Contact us