Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.
NCT ID: NCT01808300
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2013-02-28
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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A-B-C
Drug will be administered to according to A-B-C sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
A-C-B
Drug will be administered to according to A-C-B sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
B-C-A
Drug will be administered to according to B-C-A sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
B-A-C
Drug will be administered to according to B-A-C sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
C-A-B
Drug will be administered to according to C-A-B sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
C-B-A
Drug will be administered to according to C-B-A sequence for 3 period.
Pregabalin 300mg, Thioctic acid 600mg
* 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
Interventions
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Pregabalin 300mg, Thioctic acid 600mg
* 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
Eligibility Criteria
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Inclusion Criteria
2. Provision of signed written informed consent
3. Acceptable physical examination and clinical examination, during screening
Exclusion Criteria
2. A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
3. A subject with history of allergies including study drug (pregabalin or thioctic acid) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
4. A subject whose lab test results are as follows: AST(SGOT), ALT(SGPT) \> 1.5 x upper limit of reference range
5. Presence or history of drug abuse or positive result in urine drug screening test
6. Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
7. Participation in clinical trials of any drug within 60 days prior to the participation of the study
8. Blood donation during 2 months or apheresis during 1 month before the study
9. Use of alcohol over 21 units/weeks
10. Smoker who smoke more than 10 cigarettes per day or who cannot stop smoking during the study period (from 24 hours before hospitalization to discharge)
11. Use of caffeine drink during the study period(from 24 hours before hospitalization to discharge)
12. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products during the study
13. Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.
20 Years
45 Years
MALE
Yes
Sponsors
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Unimed Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-Sang Yu
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
References
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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.
Other Identifiers
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H-1212-030-449
Identifier Type: REGISTRY
Identifier Source: secondary_id
UMPT-1
Identifier Type: -
Identifier Source: org_study_id