Peripheral (Sensorimotor) Diabetic PolyneuropathyPhase 1NCT04214665
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
A Phase 1 study testing Alpha Lipoic acid 600 mg HR film coated tablets in people with Peripheral (Sensorimotor) Diabetic Polyneuropathy, run by Ilko Ilac San. ve Tic. A.S..
Trial summary
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S. versus reference Thioctacid (Alpha Lipoic acid) 600 mg HR film coated tablets of Meda Pharma GmbH\& CO .KG, Germany. Read more about this study
- Who is it for?
- Ages 22 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peripheral (Sensorimotor) Diabetic Polyneuropathy
- What is being tested?
- Alpha Lipoic acid 600 mg HR film coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2014to 21 Apr 2015
- 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 22 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Human subjects aged from 22 to 45 years (inclusive of both).
- BMI range from 18.5 to 30.0 kg/m2 inclusive with the bodyweight is::>: 45 kgs.
- Normal vital signs (Blood pressure, pulse rate, respiratory rate and body temperature).
- Normal medical and surgical history as determined by the physician or principal investigator prior to start of the study.
- Normally functioning of cardiovascular, respiratory, gastrointestinal, nervous system, musculoskeletal, vascular, genitourinary, endocrine/metabolic systems.
- Normal 12-lead electrocardiogram (ECG).
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- Normal chest X-Ray (PIA view).
- Subjects able to communicate effectively.
- Willing to provide informed consent and adhere to the protocol requirements.
Who cannot join
- Contraindications or hypersensitivity to Alpha Lipoic acid or any of the excipients.
- History or presence of any disease (Gastric, renal, respiratory, cardiac, neurological etc.) according to the opinion of the physician.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 09 cigarettes or bidis/day) or consumption of tobacco products (pan, gutkha) and refusal to restrain from smoking for 48.00 hours before first period check-in until last sampling.
- History or presence of significant asthma, urticaria or other allergic reactions.
- History of difficulty in donating blood or difficulty in accessibility of veins.
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- Difficulty in swallowing tablets.
- Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
- Diastolic blood pressure less than 70mm Hg or more than 89 mm Hg.
- Pulse rate less than 60/minute or more than 1 00/minute.
- Use of any prescribed medication during last two weeks or OTC medicines or herbal medicinal products during the last one week preceding the first period check-in until completion of the study.
- Major illness during 3 months before screening.
- Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Refusal to abstain from water for at least 01.00 hour prior to dosing and for at least 02.00 hours post dose.
- Refusal to abstain from food for at least 10.00 hours before scheduled time for dosing and for at least 04.00 hours post dose.
- Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee, tea, carbonated drinks, chocolate) from 48.00 hours prior to first period checkin until last sampling.
- Presence of disease markers hepatitis B \& C virus \& VDRL.
- HIV positive.
- Positive alcohol breath test at the time of check-in.
- Positive in the urine drugs of abuse at the time of check-in.
- Evidence of an uncooperative attitude.
About this study
Official title: A Randomized, Open-label, Balanced, Two-treatment, Four-period, Two-sequence, Single Dose, Fully Replicate, Crossover, Oral Bioequivalence Study of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Llko Ilac San. Ve Tic. A.S., Turkey and Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany in 28 Healthy, Adult, Human Subjects Under Fasting Conditions.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S. versus reference Thioctacid (Alpha Lipoic acid) 600 mg HR film coated tablets of Meda Pharma GmbH\& CO .KG, Germany.
- Being tested
- Alpha Lipoic acid 600 mg HR film coated tablets
- Keywords
- alpha-lipoic acid, bioequivalence, replicate design
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic acid 600 mg HR film coated tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Test/Reference | Experimental | Single dose of test tablet in period I. Followed by single dose of reference tablet in period II. First and second dose administration will be separated by a washout period of at least 5 days. Receives: Drug: Alpha Lipoic acid 600 mg HR film coated tablets |
| Reference/Test | Experimental | Single dose of reference tablet in period I. Followed by single dose of test tablet in period II. First and second dose administration will be separated by a washout period of at least 5 days. Receives: Drug: Alpha Lipoic acid 600 mg HR film coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
AUC0-t
Area under the plasma concentration vs. time curve till last measured time point
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Secondary outcomes (5)
AUC0-∞
Area under the plasma concentration vs. time curve extrapolated to infinity
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
T max
Time to achieve peak plasma concentration
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
t1/2
Plasma elimination half-life
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Kel
Elimination rate constant
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
(AUC0-inf - AUC0-t) / AUC0-inf
Residual area
Measured: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start30 Dec 2014
- Primary completion24 Jan 2015
- Study completion21 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral (Sensorimotor) Diabetic PolyneuropathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilko Ilac San. ve Tic. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214665
- Sponsor's protocol ID
- 070-14-TR
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Balanced, Two-treatment, Four-period, Two-sequence, Single Dose, Fully Replicate, Crossover, Oral Bioequivalence Study of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Llko Ilac San. Ve Tic. A.S., Turkey and Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany in 28 Healthy, Adult, Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT04214665
- Acronym / sponsor ID
- 070-14-TR
- Keywords
- alpha-lipoic acid, bioequivalence, replicate design
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ilko Ilac San. ve Tic. A.S.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2014 (actual)
- Primary completion
- 24 Jan 2015 (actual)
- Study completion
- 21 Apr 2015 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S. versus reference Thioctacid (Alpha Lipoic acid) 600 mg HR film coated tablets of Meda Pharma GmbH\& CO .KG, Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Reference | Experimental | Drug: Alpha Lipoic acid 600 mg HR film coated tabletsSingle dose of test tablet in period I. Followed by single dose of reference tablet in period II. First and second dose administration will be separated by a washout period of at least 5 days. |
| Reference/Test | Experimental | Drug: Alpha Lipoic acid 600 mg HR film coated tabletsSingle dose of reference tablet in period I. Followed by single dose of test tablet in period II. First and second dose administration will be separated by a washout period of at least 5 days. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Human subjects aged from 22 to 45 years (inclusive of both).
- BMI range from 18.5 to 30.0 kg/m2 inclusive with the bodyweight is::>: 45 kgs.
- Normal vital signs (Blood pressure, pulse rate, respiratory rate and body temperature).
- Normal medical and surgical history as determined by the physician or principal investigator prior to start of the study.
- Normally functioning of cardiovascular, respiratory, gastrointestinal, nervous system, musculoskeletal, vascular, genitourinary, endocrine/metabolic systems.
Key exclusion criteria (23 listed)
- Contraindications or hypersensitivity to Alpha Lipoic acid or any of the excipients.
- History or presence of any disease (Gastric, renal, respiratory, cardiac, neurological etc.) according to the opinion of the physician.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 09 cigarettes or bidis/day) or consumption of tobacco products (pan, gutkha) and refusal to restrain from smoking for 48.00 hours before first period check-in until last sampling.
- History or presence of significant asthma, urticaria or other allergic reactions.
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 |
|---|---|---|
| Alpha Lipoic acid 600 mg HR film coated tablets | Drug | Reference/Test, Test/Reference |
Primary outcome
Cmax
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Peak plasma concentration
AUC0-t
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Area under the plasma concentration vs. time curve till last measured time point
5 secondary outcomes
AUC0-∞
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
T max
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
t1/2
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
Kel
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
(AUC0-inf - AUC0-t) / AUC0-inf
Time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.
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 3 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpha Lipoic acid 600 mg HR film coated tablets in people with Peripheral (Sensorimotor) Diabetic Polyneuropathy, run by Ilko Ilac San. ve Tic. A.S..
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 9 inclusion and 23 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 3 Jan 2020. 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?
Cmax (time frame: pre-dose [(0.00) within 2.00 hours prior to dosing] and at 0.083, 0.167, 0.25, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50,. 3.00, 4.00, 5.00, 6.00 hours post-dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2020.