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 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.

Study Overview

• Status: Completed
• Conditions: Peripheral (Sensorimotor) Diabetic Polyneuropathy
• Intervention / Treatment: Drug: Alpha Lipoic acid 600 mg HR film coated tablets

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Reference; 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.	Drug: Alpha Lipoic acid 600 mg HR film coated tablets
Experimental: Reference/Test; 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.	Drug: Alpha Lipoic acid 600 mg HR film coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak plasma concentration	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	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 Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞	Area under the plasma concentration vs. time curve extrapolated to infinity	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Ilko Ilac San. ve Tic. A.S.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2014
• Primary Completion (Actual): January 24, 2015
• Study Completion (Actual): April 21, 2015

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: bioequivalence; alpha-lipoic acid; replicate design
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: 070-14-TR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No