Pharmacokinetic Properties and Bioequivalence of Two Sulfadoxine/Pyrimethamine Fixed-Dose Combination Tablets: A Parallel-Design Study in Healthy Chinese Male Volunteers

Liu, Yanmei; Zhang, Kanyin E.; Liu, Yun; Zhang, Haichen; Song, Yanting; Pu, Huahua; Lü, Chuan; Liu, Gangyi; Jia, Jingying; Zheng, Qingsi; Zhu, Jie; Chen, Yu

doi:10.1016/j.clinthera.2012.10.001

Cited by 12 publications

(9 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…where θ denotes some guessed parameter vector of means and variances for test and reference formulations. Wang and Chow [3] provided an approximation of (7) and thus the determination of sample size could be derived by a closed-form solution. Furthermore, they assumed that n = km is large enough with a positive integer k; it then follows that t 1 À α,m À 1 ≈ t 1 À α,n À 1 ≈ z 1 À α , where z p denotes the 100pth quantile of standard normal distribution.…”

Section: The Current Sample Size Determinationmentioning

confidence: 99%

See 1 more Smart Citation

An approach for sample size determination of average bioequivalence based on interval estimation

Chiang

Hsiao

2017

Statistics in Medicine

View full text Add to dashboard Cite

In 1992, the US Food and Drug Administration declared that two drugs demonstrate average bioequivalence (ABE) if the log-transformed mean difference of pharmacokinetic responses lies in (-0.223, 0.223). The most widely used approach for assessing ABE is the two one-sided tests procedure. More specifically, ABE is concluded when a 100(1 - 2α) % confidence interval for mean difference falls within (-0.223, 0.223). As known, bioequivalent studies are usually conducted by crossover design. However, in the case that the half-life of a drug is long, a parallel design for the bioequivalent study may be preferred. In this study, a two-sided interval estimation - such as Satterthwaite's, Cochran-Cox's, or Howe's approximations - is used for assessing parallel ABE. We show that the asymptotic joint distribution of the lower and upper confidence limits is bivariate normal, and thus the sample size can be calculated based on the asymptotic power so that the confidence interval falls within (-0.223, 0.223). Simulation studies also show that the proposed method achieves sufficient empirical power. A real example is provided to illustrate the proposed method. Copyright © 2017 John Wiley & Sons, Ltd.

show abstract

Section: The Current Sample Size Determinationmentioning

confidence: 99%

“…Here two scenarios for the value of μ D are considered. If μ D = 0, then the approximation of power (7) can be written as…”

Section: The Current Sample Size Determinationmentioning

confidence: 99%

An approach for sample size determination of average bioequivalence based on interval estimation

Chiang

Hsiao

2017

Statistics in Medicine

View full text Add to dashboard Cite

show abstract

“…commonly used ACT treatments are artemether-lumefantrine, artesunate-amodiaquine, dihydoartemisinin-piperaquine, artesunate-mefloquine, and artesunate plus sulfadoxinepyrimethamine (SP) (1,(7)(8)(9). Artemisinin derivatives rapidly eliminate the parasites by up to 4 logs in 48 h of the asexual cycle and have a high rate of parasite clearance (10)(11)(12)(13). To avoid recrudescence, a therapeutic concentration should be maintained for three life cycles by multiple-dose administration (12,14).…”

mentioning

confidence: 99%

“…Sulfadoxine and pyrimethamine inhibit dihydrofolate reductase of plasmodia, which is essential in the biosynthesis of tetrahydrofolate. Sulfadoxine and pyrimethamine have long halflives of ϳ169 h and ϳ111 h, respectively (10,17). ␣/␤-Arteether is a substrate of CYP3A4/5, whereas sulfadoxine-pyrimethamine does not interact with CYP3A4/5 (18,19).…”

mentioning

confidence: 99%

See 1 more Smart Citation

Assessment of Clinical Pharmacokinetic Drug-Drug Interaction of Antimalarial Drugs α/β-Arteether and Sulfadoxine-Pyrimethamine

Chhonker

Bhosale

Sonkar

et al. 2017

Antimicrob Agents Chemother

View full text Add to dashboard Cite

Antimalarial drug combination therapy is now being widely used for the treatment of uncomplicated malaria. The objective of the present study was to investigate the effects of coadministration of intramuscular α/β-arteether (α/β-AE) and oral sulfadoxine-pyrimethamine (SP) on the pharmacokinetic properties of each drug as a drug-drug interaction study to support the development of a fixed-dose combination therapy. A single-dose, open-label, crossover clinical trial was conducted in healthy adult Indian male volunteers (18 to 45 years, = 13) who received a single dose of AE or SP or a combination dose of AE and SP. Blood samples were collected up to 21 days postadministration, and concentrations of α-AE, β-AE, sulfadoxine, and pyrimethamine were determined by using a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated and statistically analyzed to calculate the geometric mean ratio and confidence interval. Following single-dose coadministration of intramuscular AE and oral SP, the pharmacokinetic properties of α/β-AE were not significantly affected, and α/β-AE had no significant effect on the pharmacokinetic properties of SP in these selected groups of healthy volunteers. However, more investigations are needed to explore this further. (This study has been registered in the clinical trial registry of India under approval no. CTRI/2011/11/002155.).

show abstract

Risk of drug resistance in Plasmodium falciparum malaria therapy—a systematic review and meta-analysis

et al. 2016

View full text Add to dashboard Cite

Plasmodium falciparum is responsible for the vast majority of the morbidity and mortality associated with malaria infection globally. Although a number of studies have reported the emergence of drug resistance in different therapies for P. falciparum infection, the degree of the drug resistance in different antimalarials is still unclear. This research investigated the risk of drug resistance in the therapies with different medications based on meta-analyses. Relevant original randomized control trials (RCTs) were searched in all available electronic databases. Pooled relative risks (RRs) with 95% confidence intervals (95% CIs) were used to evaluate the risk of drug resistance resulting from different treatments. Seventy-eight studies were included in the meta-analysis to compare drug resistance in the treatment of P. falciparum infections and yielded the following results: chloroquine (CQ) > sulfadoxine-pyrimethamine (SP) (RR = 3.67, p < 0.001 ), mefloquine (MQ) < SP (RR = 0.26, p < 0.001), artesunate + sulfadoxine-pyrimethamine (AS + SP) > artemether + lumefantrine (AL) (RR = 2.94, p < 0.001), dihydroartemisinin + piperaquine (DHA + PQ) < AL (RR = 0.7, p < 0.05), and non-artemisinin-based combination therapies (NACTs) > artemisinin-based combination therapies (ACTs) (RR = 1.93, p < 0.001); no significant difference was found in amodiaquine (AQ) vs. SP, AS + AQ vs. AS + SP, AS + AQ vs. AL, or AS + MQ vs. AL. These results presented a global view for the current status of antimalarial drug resistance and provided a guidance for choice of antimalarials for efficient treatment and prolonging the life span of the current effective antimalarial drugs.

show abstract

Pharmacokinetic Properties and Bioequivalence of Two Sulfadoxine/Pyrimethamine Fixed-Dose Combination Tablets: A Parallel-Design Study in Healthy Chinese Male Volunteers

Cited by 12 publications

References 13 publications

An approach for sample size determination of average bioequivalence based on interval estimation

An approach for sample size determination of average bioequivalence based on interval estimation

Assessment of Clinical Pharmacokinetic Drug-Drug Interaction of Antimalarial Drugs α/β-Arteether and Sulfadoxine-Pyrimethamine

Risk of drug resistance in Plasmodium falciparum malaria therapy—a systematic review and meta-analysis

Contact Info

Product

Resources

About