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Completed

NCT Number: NCT01808300

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin 300mg, Thioctic acid 600mg

Drug
  • 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Unimed Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2013
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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