Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pregabalin 300mg, Thioctic acid 600mg

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
2. Provision of signed written informed consent
3. Acceptable physical examination and clinical examination, during screening

Exclusion Criteria:

1. 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
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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-B-C; Drug will be administered to according to A-B-C sequence for 3 period.	Drug: 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
Experimental: A-C-B; Drug will be administered to according to A-C-B sequence for 3 period.	Drug: 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
Experimental: B-C-A; Drug will be administered to according to B-C-A sequence for 3 period.	Drug: 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
Experimental: B-A-C; Drug will be administered to according to B-A-C sequence for 3 period.	Drug: 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
Experimental: C-A-B; Drug will be administered to according to C-A-B sequence for 3 period.	Drug: 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
Experimental: C-B-A; Drug will be administered to according to C-B-A sequence for 3 period.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Unimed Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 3, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Estimate): August 22, 2013
• Last Update Submitted That Met QC Criteria: August 21, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Protective Agents; Micronutrients; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Vitamins; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Vitamin B Complex; Pregabalin; Thioctic Acid
• Other Study ID Numbers: UMPT-1; H-1212-030-449 (Registry Identifier: H-1212-030-449)