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Table 4 Summary of pharmacokinetic parameters for UDCA after administration of single and multiple doses of BUDCA

From: Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia

 

Parameter

250 mg/dose

500 mg/dose

1000 mg/dose

Day 1

AUClast (hr.ng/mL)

3680 (± 1280)

8530 (± 4600)

15,500 (± 5830)

 

Cmax (ng/mL)

923 (± 453)

1730 (± 873)

2900 (± 1520)

 

Tmax (hr)

2.0 [0.5–4.0]

3.0 [1.0–4.1]

4.0 [1.0–8.0]

 

T1/2 (hr)

2.8 (± 0.9)

6.8 (± 9.9)

5.2 (± 1.6)

Day 28

AUClast (hr.ng/mL)

12,000 (± 16,900)

15,100 (± 6780)

2940 (± 10,600)

 

Cmax (ng/mL)

1660 (± 275)

1940 (± 801)

3370 (966)

 

Tmax (ng/mL)

3.0 [2.0–12.0]

4.0 [2.0–8.0]

3.5 [0–4.0]

 

T1/2 (hr)

N.D.

6.7 (± 2.9)

7.5 (± 2.8)

  1. AUClast area under plasma concentration-time curve to last quantifiable measurement, Cmax maximum observed plasma concentration, Tmax time to maximum concentration, T1/2 terminal half life