A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Thioctic acid after oral administration in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
42
* A: Pregabalin - Pregabalin 300mg will be administered orally twice a day for 3 days * B: Thioctic acid - Thioctic acid 600mg will be administered orally once a day for 3 days * C: Pregabalin plus Thioctic acid - Pregabalin plus Thioctic acid same way as A and B
AUCτ,ss / Cmax of pregabalin and thioctic acid
Time frame: 2d (9d, 16d): 0h (predose:Thioctic acid), 12h (pre-dose:Pregabalin), 3d(10d, 17d): 0h (pre-dose), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12h, 24h
Ctrough,ss / Tmax,ss / t½ / CL/F of pregabalin and thioctic acid
Time frame: 2d (9d, 16d): 0h (predose:Thioctic acid), 12h (pre-dose:Pregabalin), 3d(10d, 17d): 0h (pre-dose), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12h, 24h
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