PMID- 37936786
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231109
IS  - 1682-024X (Print)
IS  - 1681-715X (Electronic)
IS  - 1681-715X (Linking)
VI  - 39
IP  - 6
DP  - 2023 Nov-Dec
TI  - Bioequivalence assessment of two Ticagrelor formulations under fasting condition 
      in healthy Pakistani subjects.
PG  - 1647-1651
LID - 10.12669/pjms.39.6.8203 [doi]
AB  - OBJECTIVE: To investigate the Bioequivalence of Anplag(R) 90mg (Ticagrelor) tablet 
      and Brilinta(R) 90 mg (Ticagrelor) tablet under fasting conditions in healthy 
      Pakistani subjects. METHOD: This was an open-label, cross-over, randomized, 
      single-dose, two-period, single-center Bioequivalence Study conducted at Center 
      of Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, University of 
      Karachi, Karachi, Pakistan from September 2020 to January 2021. This was an 
      open-label, randomized, single-dose, two-period, cross-over Bioequivalence Study. 
      After randomization, a single dose of Ticagrelor 90mg tablet (test or reference 
      drug) were administered orally in 1:1 ratio to each subject under fasting 
      conditions. Seven days washout period was kept between the two periods in order 
      to avoid carry over. Blood samples were then taken up to 48th hours post-dose. 
      Point estimates and 90% confidence intervals (CI) for the ratio of the 
      log-transformed values were calculated. Bioequivalence assessment of both, the 
      reference and the test drugs were based on the primary Pharmacokinetic PK metrics 
      including peak maximum concentration (Cmax), area under the curve (AUC) from zero 
      to last quantifiable concentration (AUClast), and AUC from zero to infinity 
      (AUCtotal) after log-transformation of data with ANOVA. In this bioequivalence 
      study, the primary pharmacokinetic parameters were assessed for both Ticagrelor 
      and its Active Metabolite (AR-C124910XX). Safety endpoints were evaluated by 
      monitoring adverse events (AEs). RESULTS: The 90% Confidence Intervals (CIs) of 
      the Geometric Mean Ratio for primary PK parameters including Cmax, AUClast, and 
      AUCtotal all were within the accepted bioequivalence range of 80%- 125%. In the 
      current study, no serious adverse events were reported. CONCLUSION: Our results 
      showed that the two tested formulations of Ticagrelor tablets were bioequivalent 
      and well tolerated.Trial Registration: ClinicalTrials.gov Identifier: 
      NCT04941196.
CI  - Copyright: (c) Pakistan Journal of Medical Sciences.
FAU - Hashmi, Naghma
AU  - Hashmi N
AD  - Naghma Hashmi Center for Bioequivalence Studies and Clinical Research, Dr. 
      Panjwani Center for Molecular Medicine and Drug Research International, Center 
      for Chemical and Biological Sciences, University of Karachi, Karachi, Pakistan.
FAU - Jawaid, Masood
AU  - Jawaid M
AD  - Masood Jawaid Director Medical Affairs, PharmEvo Private Limited, 402, Business 
      Avenue, Block-6, P.E.C.H.S., Shahrah-e-Faisal, Karachi, Pakistan.
FAU - Shah, Muhammad Raza
AU  - Shah MR
AD  - Muhammad Raza Shah Center for Bioequivalence Studies and Clinical Research, Dr. 
      Panjwani Center for Molecular Medicine and Drug Research International, Center 
      for Chemical and Biological Sciences, University of Karachi, Karachi, Pakistan.
LA  - eng
SI  - ClinicalTrials.gov/NCT04941196
PT  - Journal Article
PL  - Pakistan
TA  - Pak J Med Sci
JT  - Pakistan journal of medical sciences
JID - 100913117
PMC - PMC10626117
OTO - NOTNLM
OT  - Bioavailability
OT  - Bioequivalence
OT  - Pharmacokinetic
OT  - Ticagrelor
COIS- Conflict of Interest: Regarding this research, no conflict of interest exists.
EDAT- 2023/11/08 06:42
MHDA- 2023/11/08 06:43
PMCR- 2023/11/01
CRDT- 2023/11/08 03:53
PHST- 2023/03/26 00:00 [received]
PHST- 2023/05/22 00:00 [revised]
PHST- 2023/05/30 00:00 [revised]
PHST- 2023/08/01 00:00 [revised]
PHST- 2023/08/16 00:00 [accepted]
PHST- 2023/11/08 06:43 [medline]
PHST- 2023/11/08 06:42 [pubmed]
PHST- 2023/11/08 03:53 [entrez]
PHST- 2023/11/01 00:00 [pmc-release]
AID - PJMS-39-1647 [pii]
AID - 10.12669/pjms.39.6.8203 [doi]
PST - ppublish
SO  - Pak J Med Sci. 2023 Nov-Dec;39(6):1647-1651. doi: 10.12669/pjms.39.6.8203.