HealthyPhase 1NCT01808300
Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.
A Phase 1 study testing Pregabalin 300mg, Thioctic acid 600mg in people with Healthy, run by Unimed Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin 300mg, Thioctic acid 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Pregabalin 300mg, Thioctic acid 600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 300mg, Thioctic acid 600mgDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| A-B-C | Experimental | Drug will be administered to according to A-B-C sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
| A-C-B | Experimental | Drug will be administered to according to A-C-B sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
| B-C-A | Experimental | Drug will be administered to according to B-C-A sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
| B-A-C | Experimental | Drug will be administered to according to B-A-C sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
| C-A-B | Experimental | Drug will be administered to according to C-A-B sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
| C-B-A | Experimental | Drug will be administered to according to C-B-A sequence for 3 period. Receives: Drug: Pregabalin 300mg, Thioctic acid 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss / Cmax of pregabalin and thioctic acid
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unimed Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808300
- Sponsor's protocol ID
- UMPT-1
- Other IDs
- H-1212-030-449
- Status last verified
- Mar 2013
- First submitted
- 3 Mar 2013
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30241687
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01808300
- Acronym / sponsor ID
- UMPT-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Unimed PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A-B-C | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to A-B-C sequence for 3 period. |
| A-C-B | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to A-C-B sequence for 3 period. |
| B-C-A | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to B-C-A sequence for 3 period. |
| B-A-C | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to B-A-C sequence for 3 period. |
| C-A-B | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to C-A-B sequence for 3 period. |
| C-B-A | Experimental | Drug: Pregabalin 300mg, Thioctic acid 600mgDrug will be administered to according to C-B-A sequence for 3 period. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | A-B-C, A-C-B, B-A-C, B-C-A, C-A-B, C-B-A |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
- Derived from this study: PubMed 30241687Rhee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregabalin 300mg, Thioctic acid 600mg in people with Healthy, run by Unimed Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.