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Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

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ClinicalTrials.gov Identifier: NCT01808300
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Unimed Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pregabalin 300mg, Thioctic acid 600mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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 Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808300


Sponsors and Collaborators
Unimed Pharmaceuticals
Investigators
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Principal Investigator: Kyung-Sang Yu Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unimed Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01808300     History of Changes
Other Study ID Numbers: UMPT-1
H-1212-030-449 ( Registry Identifier: H-1212-030-449 )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Pregabalin
Thioctic Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antioxidants
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances