AbstractA single‐center, randomized, open, 2‐period, self‐crossover, single‐dose trial was conducted to evaluate the bioequivalence of the test (T) and reference (R) preparations in healthy adult female subjects under fasting conditions. Seventy‐six subjects were enrolled in the study, and subjects were randomly divided into 2 groups at a 1:1 ratio and were administered once per period, with a 4‐day washout period. In each period, plasma drug concentrations, blood calcium changes, and antibodies were determined for pharmacokinetics, pharmacodynamics, and immunogenicity analysis, respectively, and adverse events were recorded for safety analysis. The 90% confidence intervals for the geometric mean ratios (T:R) of maximum plasma concentration, area under the plasma concentration‐time curve from time 0 to the last measurable concentration, and area under the plasma concentration‐time curve from time 0 to infinity were within the predefined bioequivalence criterion of 80%‐125%, indicating bioequivalence between the T and R preparations under fasting conditions. Comparable serum calcium levels demonstrated pharmacodynamics similarity, and no differences were found in immunogenicity profiles. Additionally, the incidence of adverse reactions to the T preparation was 18.4% lower than that of the R preparation (31.6%). This study confirmed the bioequivalence of the T and R preparations under fasting conditions, along with comparable immunogenicity profiles and good safety.

2021-01-01·Strategies in Trauma and Limb Reconstruction

An Initial Study into the Role of Teriparatide in Absent or Delayed Regenerate Formation during Distraction Osteogenesis: A Case Series

Article

作者: Patil, Bharath ; Kapoor, Anil ; Mittal, Naveen ; Gupta, Sandeep ; Sharma, Anmol ; Kansay, Rajeev

PurposeDistraction osteogenesis has been used for post-traumatic segmental bone defects. Absent or delayed callus formation in the distraction gap can lead to significant morbidity and affect the clinical outcome. Experimental evidence in animal models has demonstrated that teriparatide enhances the consolidation of regenerate and also strengthens it. This study aimed to report our experience with recombinant teriparatide therapy for patients with regenerate insufficiency.Materials and methodsNine out of 43 patients undergoing limb lengthening using the limb reconstruction system (LRS) fixator were diagnosed with regenerate insufficiency. With informed consent, these patients received a therapeutic regime of 20 μg of teriparatide administered subcutaneously once daily for a period of 3 months.ResultsThe mean age in the sample was 40.22 years (SD 17.87). Regenerate insufficiency was diagnosed at a mean of 4.94 months (range 2.5-9 months) from surgery. Teriparatide injections were started at a mean of 6.94 months (range 4.5-11 months) from surgery. The sites of regenerate insufficiency were tibia (n = 5) and femur (n = 4). Favourable radiographic progress in visibility of callus was seen at a mean duration of 9.4 weeks (range 8-12 weeks) from the initiation of teriparatide therapy. No systemic complications were encountered.ConclusionThe initiation of teriparatide treatment as described in this study may be successful in triggering the osteogenic potential within poor regenerate and help in consolidation and avoid more invasive surgical procedures.How to cite this articlePatil B, Kansay R, Gupta S, et al. An Initial Study into the Role of Teriparatide in Absent or Delayed Regenerate Formation during Distraction Osteogenesis: A Case Series. Strategies Trauma Limb Reconstr 2020;15(2):117-120.

2016-08-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Relative bioavailability between two teriparatide formulations in healthy volunteers

4区 · 医学

Article

作者: Diez, Roberto A. ; Papouchado, Mariana ; Criscuolo, Marcelo E. ; Di Girolamo, Guillermo ; VillaEtchegoyen, Marιa C. ; Keller, Guillermo A. ; Farιas, Javier

OBJECTIVETo compare the pharmacokinetics, relative bioavailability (RB), immunogenicity, and safety after a single dose of test or reference formulation of teriparatide in healthy human volunteers in order to demonstrate whether both products are similar.RESEARCH DESIGN AND METHODSWe compared pharmacokinetic parameters, immunogenicity, and safety after a single dose of two formulations (Osteofortil® and Forteo®) of teriparatide in a randomizedsequence, open-label, two-period crossover study in 24 healthy volunteers. The washout period between formulations was 7 days. Blood samples were collected at baseline and 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150 minutes, and 3 and 4 hours after administration. Teriparatide concentrations were determined using ELISA. Adverse events were monitored.RESULTSGeometric mean (90% CI) Cmax for test and reference formulations were 165.86 (153.35 - 212.13) and 175.37 (164.04 - 221.04) pg/mL, the AUC0-t was 14,932 (5,275 - 15,752) and 14,153 (1,861 - 16,875) pg×min/mL, and the AUC0-∞ was 16,147 (15,047 - 18,799) and 15,467 (14,473 - 18,126) pg×min/mL, respectively. The test/reference ratios (90% CI) for Cmax, AUC0-t, and AUC0-∞ were 94.58% (85.29 - 104.87), 105.5% (97.77 - 113.84), and 104.4% (96.97 - 112.39), respectively No subject reported adverse events.CONCLUSIONTest formulation met pharmacokinetic criteria for bioequivalence.

100 项与特立帕肽生物类似药(Biosidus SA) 相关的药物交易

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