Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects

Harahap, Yahdiana; Prasaja, Budi; Azmi, Fahmi; Lusthom, Windy; Sinandang, Theresia; Felicia,; Ly, Yusvita; Ly, Panjaitan

doi:10.5414/cp202345

Cited by 6 publications

(5 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In light of the pilot study results and previous studies, the sample size of 24 was sufficient to correctly evaluate bioequivalence under the following conditions: within-subject CVs of 14.38%-21.24% for pharmacokinetic parameters and GMR range of 0.95-1.05. [17][18][19][20] In consideration of possible dropouts, we enrolled 28 subjects in both the fasted and fed studies.…”

Section: Discussionmentioning

confidence: 99%

“…With respect to sample size, in accordance with the Statistical Guidelines for Bioequivalence Studies published by the NMPA in 2018, there are several factors that need to be considered: α = 0.05 in the two one‐sided T tests, power ≥80%, within‐subject CV based on the published studies and pilot study, GMR, acceptance criteria of 0.8–1.25 for bioequivalence studies. In light of the pilot study results and previous studies, the sample size of 24 was sufficient to correctly evaluate bioequivalence under the following conditions: within‐subject CVs of 14.38%–21.24% for pharmacokinetic parameters and GMR range of 0.95–1.05 17–20 . In consideration of possible dropouts, we enrolled 28 subjects in both the fasted and fed studies.…”

Section: Discussionmentioning

confidence: 99%

“…The relationships between AEs and study drugs were determined by experienced researchers when AEs emerged during the study. A rosuvastatin bioequivalence study was performed by Harahap et al 19 in 24 healthy subjects and the results showed that a total of 17 AEs occurred throughout the study after single‐dose oral administration of 40 mg of rosuvastatin. These AEs were certainly or probably related to the study drug.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions

Zhu

Wang

Li³

et al. 2022

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

The main objective of the study was to evaluate the bioequivalence of two rosuvastatin calcium tablets in healthy Chinese subjects under fasted and fed conditions. The study was carried out using a randomized, open‐label, two‐formulation, two‐sequence, two‐period, single‐dose crossover design, with a washout period of 7 days. Both the fasted study and fed study enrolled 28 subjects. In each study period, the subjects were administrated a single oral dose of the test product or reference product of rosuvastatin 10 mg. Blood samples were collected from pre‐dose to 72 hours after administration with 16 time points in total. Bioequivalence evaluation was performed using ln‐transformed pharmacokinetic parameters of rosuvastatin, including Cmax, AUC0–t, and AUC0–∞. In the present study, 95% confidence intervals (CIs) of test/reference geometric mean ratios (GMRs) of Cmax, AUC0–t, and AUC0–∞ under the fasted and fed conditions were all within the acceptance range of 80%–125%. Additionally, only one subject experienced one adverse event (AE). High‐fat meals reduced the Cmax, AUC0–t, and AUC0–∞, but had no significant effects on the λz, t1/2, or Tmax of rosuvastatin. In the current study, the test product was bioequivalent to the reference product, and a single dose of rosuvastatin (10 mg) was well‐tolerated. Food decreased the systemic exposure of rosuvastatin without the effects on the Tmax or elimination rate.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions

Zhu

Wang

Li³

et al. 2022

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

show abstract

“…To validate our results, we compared our data to other ethnic groups in 3 highly replicated generic drugs. IntraCVs of C max were 21.2% for rosuvastatin in Indonesian, [18] 29.0% for celecoxib in Taiwan [19] and 20.2% for duloxetine in Thai subjects. [20] All of them were quite similar to our results.…”

Section: Discussionmentioning

confidence: 99%

A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies

Chung

Lee

et al. 2018

Transl Clin Pharmacol

View full text Add to dashboard Cite

Because bioequivalence studies are performed using a crossover design, information on the intrasubject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs based on bioequivalence results of identical generic drugs produce different estimates. In this study, we collected bioequivalence results using public resources from the Ministry of Food and Drug Safety (MFDS) and calculated the intraCVs of various generics. For the generics with multiple bioequivalence results, pooled intra-CVs were calculated. The estimated intra-CVs of 142 bioequivalence studies were 14.7±8.2% for AUC and 21.7±8.8% for C max . Intra-CVs of C max were larger than those of area under the concentrationtime curve (AUC) in 129 studies (90.8%). For the 26 generics with multiple bioequivalence results, the coefficients of variation of intra-CVs between identical generics (mean±sd (min ~ max)) were 38.0±24.4% (1.9 ~ 105.3%) for AUC and 27.9±18.2% (4.0 ~ 70.1%) for C max . These results suggest that substantial variation exists among the bioequivalence results of identical generics. In this study, we presented the intra-CVs of various generics with their pooled intra-CVs. The estimated intraCVs calculated in this study will provide useful information for planning future bioequivalence studies. (This is republication of the article 'Transl Clin Pharmacol 2017;25:179-182

show abstract

“…6,7 The modified release tablet containing 35 mg of trimetazidine maintains sustained 24-hour coverage with only one tablet in the morning and one in evening. 8 There is lack of real-world evidence on various aspects of CSA management in India. The objective of conducting this questionnaire-based survey was to garner real-world data about the prevalence of CSA among Indian patients; the associated comorbidities among these patients; management practices for CSA in India; and factors affecting compliance in patients with CSA with a special focus on day and night pack for trimetazidine controlled release (CR) 35 mg twice daily (BD) tablets.…”

Section: Trimetazidinementioning

confidence: 99%

A nationwide questionnaire-based survey on practice patterns and management of chronic stable angina with a controlled release formulation of trimetazidine

Balachandran¹,

Jaganathan²,

Jhala³

et al. 2021

Int J Adv Med

View full text Add to dashboard Cite

Background: There is lack of real-world evidence on various aspects of chronic stable angina (CSA). Hence, a questionnaire-based survey was conducted to garner real-world data about the prevalence of CSA among Indian patients; the associated comorbidities among these patients; management practices for CSA in India; and factors affecting compliance in patients with CSA with a special focus on day and night pack for trimetazidine controlled release (CR) 35 mg BD tablets.Methods: In all, 100 health care practitioners (HCPs) who each observed 15 patients with CSA in their clinical practice participated in this quantitative, cross-sectional, questionnaire-based study. The data were collected using a structured questionnaire with 30 questions grouped into 5 sections. Data were analyzed using percentages.Results: The results from the survey showed that 52.7% HCPs had observed 31-50% of angina patients with diabetes mellitus as comorbidity. As per the questionnaire survey, 77.4% HCPs preferred trimetazidine as a second-line agent when an angina patient was not responding to beta-blockers, calcium channel blockers (CCBs), and nitrates. Furthermore, 30.1% of HCPs preferred trimetazidine CR 35 mg BD as it improved exercise tolerance as well. Results from the survey reported that 65.6% HCPs agreed with the statement that day and night packs of trimetazidine tablets help in improving patient compliance and adherence to therapy.Conclusions: Trimetazidine CR 35 mg BD appears to have a safety profile suitable for various conditions and for patients with multiple comorbidities. Trimetazidine day and night packs of tablets help in improving patient compliance and adherence to therapy.

show abstract

Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects

Abstract: These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.

Cited by 6 publications

References 7 publications

Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions

Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions

A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies

A nationwide questionnaire-based survey on practice patterns and management of chronic stable angina with a controlled release formulation of trimetazidine

Contact Info

Product

Resources

About