Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

August 21, 2013 updated by: Unimed Pharmaceuticals

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
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
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
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
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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