Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-1212-030-449 | Registry Identifier | H-1212-030-449 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-B-C | Experimental | Drug will be administered to according to A-B-C sequence for 3 period. |
|
| A-C-B | Experimental | Drug will be administered to according to A-C-B sequence for 3 period. |
|
| B-C-A | Experimental | Drug will be administered to according to B-C-A sequence for 3 period. |
|
| B-A-C | Experimental | Drug will be administered to according to B-A-C sequence for 3 period. |
|
| C-A-B | Experimental | Drug will be administered to according to C-A-B sequence for 3 period. |
|
| C-B-A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 300mg, Thioctic acid 600mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss / Cmax of pregabalin and thioctic acid | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough,ss / Tmax,ss / t½ / CL/F of pregabalin and thioctic acid | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu | Seoul National University Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30241687 | Derived | Rhee SJ, Lee H, Ahn LY, Lim KS, Yu KS. Lack of a Clinically Significant Pharmacokinetic Interaction Between Pregabalin and Thioctic Acid in Healthy Volunteers. Clin Ther. 2018 Oct;40(10):1720-1728.e2. doi: 10.1016/j.clinthera.2018.08.016. Epub 2018 Sep 18. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Drug will be administered to according to C-B-A sequence for 3 period.
|
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |