Back to resultsTo 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.
Primary Purpose
Peripheral (Sensorimotor) Diabetic Polyneuropathy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Alpha Lipoic acid 600 mg HR film coated tablets
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral (Sensorimotor) Diabetic Polyneuropathy focused on measuring alpha-lipoic acid, bioequivalence, replicate design
Eligibility Criteria
Inclusion Criteria:
- 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).
- Normal chest X-Ray (PIA view).
- Subjects able to communicate effectively.
- Willing to provide informed consent and adhere to the protocol requirements.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Test/Reference
Reference/Test
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Cmax
Peak plasma concentration
AUC0-t
Area under the plasma concentration vs. time curve till last measured time point
Secondary Outcome Measures
AUC0-∞
Area under the plasma concentration vs. time curve extrapolated to infinity
T max
Time to achieve peak plasma concentration
t1/2
Plasma elimination half-life
Kel
Elimination rate constant
(AUC0-inf - AUC0-t) / AUC0-inf
Residual area
Full Information
NCT ID
NCT04214665
First Posted
December 30, 2019
Last Updated
January 2, 2020
Sponsor
Ilko Ilac San. ve Tic. A.S.
1. Study Identification
Unique Protocol Identification Number
NCT04214665
Brief Title
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2014 (Actual)
Primary Completion Date
January 24, 2015 (Actual)
Study Completion Date
April 21, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ilko Ilac San. ve Tic. A.S.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral (Sensorimotor) Diabetic Polyneuropathy
Keywords
alpha-lipoic acid, bioequivalence, replicate design
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test/Reference
Arm Type
Experimental
Arm Description
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.
Arm Title
Reference/Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alpha Lipoic acid 600 mg HR film coated tablets
Primary Outcome Measure Information:
Title
Cmax
Description
Peak plasma concentration
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.
Title
AUC0-t
Description
Area under the plasma concentration vs. time curve till last measured time point
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.
Secondary Outcome Measure Information:
Title
AUC0-∞
Description
Area under the plasma concentration vs. time curve extrapolated to infinity
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.
Title
T max
Description
Time to achieve peak plasma concentration
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.
Title
t1/2
Description
Plasma elimination half-life
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.
Title
Kel
Description
Elimination rate constant
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.
Title
(AUC0-inf - AUC0-t) / AUC0-inf
Description
Residual area
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Normal chest X-Ray (PIA view).
Subjects able to communicate effectively.
Willing to provide informed consent and adhere to the protocol requirements.
Exclusion Criteria:
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.
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.
12. IPD Sharing Statement
Learn more about this trial
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.
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