Who is sponsoring NCT04214665?

NCT04214665 is sponsored by Ilko Ilac San. ve Tic. A.S..

What drugs are being tested in NCT04214665?

Interventions in NCT04214665: Alpha Lipoic acid 600 mg HR film coated tablets.

What condition does NCT04214665 study?

NCT04214665 studies Peripheral (Sensorimotor) Diabetic Polyneuropathy.

Is NCT04214665 still recruiting?

NCT04214665 is currently completed. Last updated 3 January 2020.

Last reviewed 2020-01-03 · How we verify

NCT04214665

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Phase 1 Last updated 3 January 2020

What this trial tests

Phase 1 trial testing Alpha Lipoic acid 600 mg HR film coated tablets in Peripheral (Sensorimotor) Diabetic Polyneuropathy in 28 participants. Completed in 21 April 2015.

Timeline

30 December 2014

Primary endpoint
24 January 2015

21 April 2015

Quick facts

Lead sponsor	Ilko Ilac San. ve Tic. A.S.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	30 December 2014
Primary completion	24 January 2015
Estimated completion	21 April 2015

Drugs / interventions tested

Alpha Lipoic acid 600 mg HR film coated tablets — full drug profile →

Conditions studied

Peripheral (Sensorimotor) Diabetic Polyneuropathy — all drugs for Peripheral (Sensorimotor) Diabetic Polyneuropathy →

Sponsor

Ilko Ilac San. ve Tic. A.S. — full company profile →

Who can join

Adults 22 to 45, male only, with Peripheral (Sensorimotor) Diabetic Polyneuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04214665 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ilko Ilac San. ve Tic. A.S.
Last refreshed: 3 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04214665.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing