Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs

Burcu Bulut; Nagehan Sarraçoğlu; Onur Pınarbaşlı

Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs

Abstract

Background and Aims: Alpha lipoic acid 600 mg HR film tablet showed high intra-subject variabilities in bioequivalence studies. In this regard, this study aims to determine whether Alpha lipoic acid 600 mg HR film coated tablet is a highly variable drug. Methods: First, a randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, two-way crossover oral bioequivalence study comparing the test product (Alpha lipoic acid HR film tablet - ILKO Pharmaceuticals, Turkey) with the reference product (Thioctacid®- Meda Pharma, Germany) was conducted in normal, healthy, adult human subjects under fasting conditions (Study 1). Secondly, a randomized, open-label, balanced, two-treatment, four-period, two-sequence, single-dose, fully replicate crossover oral bioequivalence study was conducted in normal, healthy, adult human subjects under fasting conditions (Study 2). Results: Study 1 failed. It had a 90% confidence interval for LnCmax (ng/mL) value between 79.69% – 138.98% with a high intra-subject coefficient of variability (ISCV=57.5%). In study 2 a 90% confidence interval for LnCmax (ng/mL) was found between 88.40% – 129.81% while the ISCV value for LnCmax was 64.5%. Conclusion: The findings suggest that bioequivalence study for Alpha lipoic acid HR film tablet should be redesigned since this is a highly variable drug. Therefore, conventional bioequivalence acceptable limits (80.0%-125.0%) should be adjusted to 69.84% – 143.19% for alpha lipoic acid.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmacology and Pharmaceutical Sciences, Health Care Administration

Journal Section

Research Article

Authors

Burcu Bulut This is me
0000-0002-9726-8577
Türkiye

Nagehan Sarraçoğlu This is me
0000-0002-1222-7339
Türkiye

Onur Pınarbaşlı ^* This is me
0000-0001-7091-683X
Türkiye

Publication Date

April 30, 2021

Submission Date

March 9, 2020

Acceptance Date

December 2, 2020

Published in Issue

Year 2021 Volume: 51 Number: 1

IZ

https://izlik.org/JA72RU55EP

Cite

RIS / Bibtex

APA

Bulut, B., Sarraçoğlu, N., & Pınarbaşlı, O. (2021). Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. İstanbul Journal of Pharmacy, 51(1), 8-15. https://izlik.org/JA72RU55EP

AMA

1.Bulut B, Sarraçoğlu N, Pınarbaşlı O. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. iujp. 2021;51(1):8-15. https://izlik.org/JA72RU55EP

Chicago

Bulut, Burcu, Nagehan Sarraçoğlu, and Onur Pınarbaşlı. 2021. “Alpha Lipoic Acid Bioequivalence Study Redesigned: A Candidate for Highly Variable Drugs”. İstanbul Journal of Pharmacy 51 (1): 8-15. https://izlik.org/JA72RU55EP.

EndNote

Bulut B, Sarraçoğlu N, Pınarbaşlı O (April 1, 2021) Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. İstanbul Journal of Pharmacy 51 1 8–15.

IEEE

[1]B. Bulut, N. Sarraçoğlu, and O. Pınarbaşlı, “Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs”, iujp, vol. 51, no. 1, pp. 8–15, Apr. 2021, [Online]. Available: https://izlik.org/JA72RU55EP

ISNAD

Bulut, Burcu - Sarraçoğlu, Nagehan - Pınarbaşlı, Onur. “Alpha Lipoic Acid Bioequivalence Study Redesigned: A Candidate for Highly Variable Drugs”. İstanbul Journal of Pharmacy 51/1 (April 1, 2021): 8-15. https://izlik.org/JA72RU55EP.

JAMA

1.Bulut B, Sarraçoğlu N, Pınarbaşlı O. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. iujp. 2021;51:8–15.

MLA

Bulut, Burcu, et al. “Alpha Lipoic Acid Bioequivalence Study Redesigned: A Candidate for Highly Variable Drugs”. İstanbul Journal of Pharmacy, vol. 51, no. 1, Apr. 2021, pp. 8-15, https://izlik.org/JA72RU55EP.

Vancouver

1.Burcu Bulut, Nagehan Sarraçoğlu, Onur Pınarbaşlı. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. iujp [Internet]. 2021 Apr. 1;51(1):8-15. Available from: https://izlik.org/JA72RU55EP