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The present study was open labelled, balanced, randomized, two treatment, two sequence, two period,single dose, cross over comparative oral Bio-equivalence of pioglitazone 45mg tablet study on 16 healthy, adult, human subjects under fasting condition. Test product and treatment with reference drug are done during every period of study. Two-period study is designed over 2 periods with wash out period of 10 days in between and single-dose study because each subject receives only a single dose in each period



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Naga Subrahmanyam, K.Madhava Rao, B.Anupama, B.Maneesha, L. Sai Priya, & M.Vikithasree. (2023). Assessment of The Bio-Equivalence by Comparing the Single Oral Dose Bioavailability of Pioglitazone Usp Tablets 45 Mg Compare with Reference Product Actos 45mg Tablet in Healthy Adult. International Journal of Research in Pharmacology & Pharmacotherapeutics, 12(2), 85-92.


  1. 1. Abdou HM. Dissolution, Bioavailability, Pennsylvania, Mack Publishing Company; 1989.
  2. 2. ACTOS (pioglitazone hydrochloride) tablet. Daily med current medication information.
  3. 3. AkulaThukaramBapuji HLVR et al. Bioequivalence testing – industry perspective. J Bioequivalence Bioavailability;2(5).
  4. 4. Shargel L, wu-Pong S, Andrew BCY. Applied Biopharmaceutics & pharmacokinetics. 5th ed.
  5. 5. Asian guidelines for ”the conduct of bioavailability and bioequivalence studies”, final draft: 21 July 2004. Adopted from ”note for guidance on the investigation of bioavailability and bioequivalence”, CPMP/EWP. London: European Agency for the Evaluation of Medicinal Products; July 26 2001/QWP/1401/98) with some adaptation for ASEAN application.
  6. 6. Bioavailability and bioequivalence requirements. Fed Regist. 1977;42:1624- 1653.
  7. 7. Bioavailability, chapter 8. Bioequivalence, and drug SelectionAuthor: Rasma Chereson reviewer: Umesh Banakar.
  8. 8. Bioequivalence requirements guidelines. Kingdom of Saudi Arabia: Saudi Food and Drug Authority, Drug Sector [draft]; May 2005.
  9. 9. Brahmankar DM, Jaiswal SB. Bio pharmaceutics and pharmacokinetics à treatise published by M.K.Jain for wallabhprakashan, printed by goyal offset works, Delhi110088. 1st ed. p. 282-305.
  10. 10. CDER. Reviewer guidance. Validation Chromatogr Methods. 1994.
  11. 11. FDA. Guidance for industry. Analytical procedures and methods validation: chemistry, manufacturing, and controls documentation, draft guidance; 2000.