- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808300
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
Intervention / Treatment
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:
- 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.
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.
|
|
Experimental: A-C-B
Drug will be administered to according to A-C-B sequence for 3 period.
|
|
Experimental: B-C-A
Drug will be administered to according to B-C-A sequence for 3 period.
|
|
Experimental: B-A-C
Drug will be administered to according to B-A-C sequence for 3 period.
|
|
Experimental: C-A-B
Drug will be administered to according to C-A-B sequence for 3 period.
|
|
Experimental: C-B-A
Drug will be administered to according to C-B-A sequence for 3 period.
|
|
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.
Sponsor
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
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)
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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