Research Article


DOI :10.26650/IstanbulJPharm.2020.0007   IUP :10.26650/IstanbulJPharm.2020.0007    Full Text (PDF)

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

Burcu BulutNagehan SarraçoğluOnur Pınarbaşlı

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.


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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://doi.org/10.26650/IstanbulJPharm.2020.0007


AMA

Bulut B, Sarraçoğlu N, Pınarbaşlı O. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. İstanbul Journal of Pharmacy. 2021;51(1):8-15. https://doi.org/10.26650/IstanbulJPharm.2020.0007


ABNT

Bulut, B.; Sarraçoğlu, N.; Pınarbaşlı, O. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. İstanbul Journal of Pharmacy, [Publisher Location], v. 51, n. 1, p. 8-15, 2021.


Chicago: Author-Date Style

Bulut, Burcu, and Nagehan Sarraçoğlu and Onur Pınarbaşlı. 2021. “Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs.” İstanbul Journal of Pharmacy 51, no. 1: 8-15. https://doi.org/10.26650/IstanbulJPharm.2020.0007


Chicago: Humanities Style

Bulut, Burcu, and Nagehan Sarraçoğlu and Onur Pınarbaşlı. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs.” İstanbul Journal of Pharmacy 51, no. 1 (Jun. 2021): 8-15. https://doi.org/10.26650/IstanbulJPharm.2020.0007


Harvard: Australian Style

Bulut, B & Sarraçoğlu, N & Pınarbaşlı, O 2021, 'Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs', İstanbul Journal of Pharmacy, vol. 51, no. 1, pp. 8-15, viewed 25 Jun. 2021, https://doi.org/10.26650/IstanbulJPharm.2020.0007


Harvard: Author-Date Style

Bulut, B. and Sarraçoğlu, N. and Pınarbaşlı, O. (2021) ‘Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs’, İstanbul Journal of Pharmacy, 51(1), pp. 8-15. https://doi.org/10.26650/IstanbulJPharm.2020.0007 (25 Jun. 2021).


MLA

Bulut, Burcu, and Nagehan Sarraçoğlu and Onur Pınarbaşlı. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs.” İstanbul Journal of Pharmacy, vol. 51, no. 1, 2021, pp. 8-15. [Database Container], https://doi.org/10.26650/IstanbulJPharm.2020.0007


Vancouver

Bulut B, Sarraçoğlu N, Pınarbaşlı O. Alpha lipoic acid bioequivalence study redesigned: a candidate for highly variable drugs. İstanbul Journal of Pharmacy [Internet]. 25 Jun. 2021 [cited 25 Jun. 2021];51(1):8-15. Available from: https://doi.org/10.26650/IstanbulJPharm.2020.0007 doi: 10.26650/IstanbulJPharm.2020.0007


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 (Jun. 2021): 8-15. https://doi.org/10.26650/IstanbulJPharm.2020.0007



TIMELINE


Submitted09.03.2020
Accepted02.12.2020
Published Online30.04.2021

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