A pivotal in vivo bioequivalence study comparing two formulations of betamethsone OV ointment using the appropriate dose duration (ED50) calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.

开始日期2024-05-08

申办/合作机构

Zenith Technology Corp. Ltd.

ACTRN12623001181695 / Completed临床4期

A pilot dose duration-response study using a branded (marketed) formulation betamethasone dipropionate called Diprosone® OV ointment to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study and using participants who demonstrate adequate vasoconstriction to topical steroids.

开始日期2024-05-01

申办/合作机构

Zenith Technology Corp. Ltd.

ACTRN12624000107527 / Completed临床1期

A pivotal in vivo bioequivalence study comparing two formulations of betamethsone ointment using the appropriate dose duration (ED50) calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.

开始日期2024-03-07

申办/合作机构

Zenith Technology Corp. Ltd.

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2021-05-20·Journal of Clinical Oncology

An open-label, fixed-sequence study to evaluate the effect of encequidar (HM30181) an oral P-gp inhibitor, on the pharmacokinetics of dabigatran etexilate (a P-gp substrate) in healthy male volunteers.

作者: Zhi, Jay ; Hung, Noelyn Anne ; Kramer, Douglas ; Hung, Tak ; Jackson, Christopher G. C. A. ; Chan, Wing Kai ; Kwan, Min-Fun Rudolf ; Cutler, David

e15060 Background: Oral co-administration of encequidar (a selective, minimally absorbed oral P-gp inhibitor) 12.9 mg with paclitaxel (a P-gp substrate) 205 mg/m2 for 3 consecutive days per week can achieve comparable AUC exposure to that of IV paclitaxel 80mg/m2 with a significantly lowered Cmax and has been demonstrated its improved tumor response with reduced neuropathy compared to IV paclitaxel 175 mg/m2 Q3W for the treatment of patients with metastatic breast cancer. Because of its pharmacology as an inhibitor of P-gp, encequidar may increase the bioavailability of orally administered drugs that are substrates of P-gp, such as dabigatran etexilate. Methods: To determine the effect of a therapeutic dose and regimen (3 once-daily 12.9 mg doses) of encequidar on the single dose PK of dabigatran etexilate, an open-label, fixed-sequence study was performed in 20 healthy male subjects. Participants received a single oral dose of dabigatran etexilate 75 mg on Day 1 of Treatment Period 1 (reference) and, after a washout period of at least 7 days, on Days 3, 17 and 31 of Treatment Period 2, after receiving once-daily oral doses 12.9 mg encequidar on Days 1 to 3 of Period 2. The PK sampling for determination of plasma concentrations of total and unconjugated dabigatran lasted up to 48 hours postdose of each dabigatran etexilate dosr. Results: Mean AUC and Cmax values for dabigatran were both increased ̃ 95% without changing t½ when dabigatran etexilate was administered 1 hour post the 3rd dose of 12.9 mg encequidar compared to when dabigatran etexilate was administered alone. When dabigatran etexilate was administered 2 weeks after encequidar administration, no apparent differences in dabigatran AUC or Cmax were detected compared to those of dabigatran etexilate alone. When administered 4 weeks after discontinuation of encequidar, dabigatran AUC and Cmax were both slightly lower than Reference dabigatran etexilate (̃ 25% lower for AUC and 34% lower for Cmax). Both unconjugated and total dabigatran PK data were analyzed and shown to be similar. Encequidar and dabigatran etexilate were well tolerated and had acceptable safety findings in this healthy subject population. Conclusions: Concomitant dosing of encequidar with dabigatran etexilate resulted in < 2-fold increase in exposure to dabigatran, which had abated by the time of the first re-test, 14 days after the last dose of encequidar. The observed changes do not warrant dose adjustment of dabigatran etexilate when administered with encequidar. Clinical trial information: ACTRN12618000791235.

2021-05-20·Journal of Clinical Oncology

An open-label, pharmacokinetic study to determine the bioavailability, safety and tolerability of single dose oral docetaxel in metastatic prostate cancer (mPC) patients treated with IV docetaxel.

作者: Kramer, Douglas ; Chan, Wing Kai ; Cutler, David ; Wang, David ; Kwan, Min-Fun Rudolf ; Chao, Tsu-Yi ; Hung, Tak ; Ou, Yen-chuan ; Hung, Noelyn Anne ; Jackson, Christopher G. C. A. ; En, Meng ; Zhi, Jay

5050 Background: Docetaxel has poor oral bioavailability in part due to extrusion by intestinal p-glycoprotein. To improve IV solubility, it is fomulated with the nonionic surfactant polysorbate 80, requiring steroid premedication to manage hypersensitivity type reactions. Oral administration has the potential to improve tolerability, reduce day-stay utilization and improve patient convenience and allows investigation of alternative dosing schedules. Oradoxel is a new combination of oral docetaxel capsules plus the novel gut-selective P-glycoprotein inhibitor encequidar (HM30181A). Methods: Patients with mPC receiving IV docetaxel were enrolled in 3 cohorts with a dose escalation schedule of Oradoxel 75 mg/m2 in Cohort 1, 150 mg/m2 in Cohort 2, 300mg/m2 in Cohort 3. Oradoxel was given 3 weeks before or after IV docetaxel treatment. Intensive PK samples were taken on days 1-5 for Oradoxel and days 1-4 for IV docetaxel. Dose limiting toxicity (DLT) or serious adverse events (SAE) were assessed per CTCAE v4.03. Results: 3 evaluable patients in each Cohort were studied. No DLT, MTD, or drug-related SAE were observed. PK parameters of Oradoxel vs IV docetaxel are summarized in the table below. Mean absolute bioavailability of Oradoxel was 15.9% (range 8-25%). PK became non linear at 300mg/m2. Conclusions: Oradoxel was well tolerated. Based on the results of this and related studies, Oradoxel 300mg/m2 in divided doses is being further evaluated in phase 2 studies. Clinical trial information: 12616000983404. [Table: see text]

2019-08-01·British Journal of Cancer1区 · 医学

Breast milk paclitaxel excretion following intravenous chemotherapy—a case report

1区 · 医学

Article

作者: Hung, Tak ; Hung, Noelyn ; Jackson, Christopher G C A ; Morris, Tessa

Breast cancer can be diagnosed during pregnancy and in the peri-partum period, and the potential exposure of a foetus or neonate to chemotherapy is of concern to mothers and clinicians. Paclitaxel is a commonly used agent in breast cancer, but little is known about its excretion in breast milk. Breastfeeding during chemotherapy has been traditionally cautioned against due to the risk of neonatal exposure to chemotherapy agents, however, data are limited. We measured serum and breast milk concentrations of paclitaxel in a 33-year-old woman with an early breast cancer diagnosed during pregnancy and treated with weekly paclitaxel 80 mg/m². We found breast milk paclitaxel levels drop below the minimum quantifiable dose at 72 h following chemotherapy, with a relative infant dose of 0.091%. Breast milk excretion of paclitaxel following a dose of 80 mg/m² is negligible at 72 h, and this may be a safe time to recommence breastfeeding following exposure.

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