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.

NCT04214665 | Completed Phase 1

• 1 other identifier: 070-14-TR
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral (Sensorimotor) Diabetic Polyneuropathy

Keywords

alpha-lipoic acid; bioequivalence; replicate design

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUC0-∞

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Drug: Alpha Lipoic acid 600 mg HR film coated tablets

Interventions

Alpha Lipoic acid 600 mg HR film coated tablets DRUG

Reference/Test; Test/Reference

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ilko Ilac San. ve Tic. A.S.: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: December 30, 2014
• Primary Completion: January 24, 2015
• Study Completion: April 21, 2015
• Last Updated: January 3, 2020

Record last verified: 2020-01