Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pregabalin 300mg, Thioctic acid 600mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2 Provision of signed written informed consent Acceptable physical examination and clinical examination, during screening Exclusion Criteria: A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease 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 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 A subject whose lab test results are as follows: AST(SGOT), ALT(SGPT) > 1.5 x upper limit of reference range Presence or history of drug abuse or positive result in urine drug screening test 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) Participation in clinical trials of any drug within 60 days prior to the participation of the study Blood donation during 2 months or apheresis during 1 month before the study Use of alcohol over 21 units/weeks 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) Use of caffeine drink during the study period(from 24 hours before hospitalization to discharge) A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products during the study Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-B-C<br>Drug will be administered to according to A-B-C sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|
| Experimental: A-C-B<br>Drug will be administered to according to A-C-B sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|
| Experimental: B-C-A<br>Drug will be administered to according to B-C-A sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|
| Experimental: B-A-C<br>Drug will be administered to according to B-A-C sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|
| Experimental: C-A-B<br>Drug will be administered to according to C-A-B sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|
| Experimental: C-B-A<br>Drug will be administered to according to C-B-A sequence for 3 period. | Drug: Pregabalin 300mg, Thioctic acid 600mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |