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Pharmacokinetics clinical trials

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NCT ID: NCT03145038 Completed - Pharmacokinetics Clinical Trials

Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects

Start date: May 16, 2017
Phase: Phase 1
Study type: Interventional

Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat in the treatment of heart failure in paediatric patients is planned under the paediatric investigational plan (PIP). In order to administer vericiguat to children, a vericiguat paediatric formulation is needed. This paediatric formulation is characterized in this study prior to its use in paediatric patients.

NCT ID: NCT03136770 Completed - Pharmacokinetics Clinical Trials

A Randomized, Open-label, Two-way Crossover Study to Assess the Pharmacokinetics and Safety of CK-30 600 mg (Compound K)

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red ginseng extracts 2.94 g after a single oral dose in healthy male volunteers

NCT ID: NCT03135951 Completed - Breast Cancer Clinical Trials

Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

Start date: May 11, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.

NCT ID: NCT03083782 Completed - Healthy Clinical Trials

Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus

ACT
Start date: April 18, 2017
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with cyclosporine and tacrolimus in healthy volunteers. The study participants will receive apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban.

NCT ID: NCT03070561 Completed - Pharmacokinetics Clinical Trials

Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Start date: January 14, 2014
Phase: Early Phase 1
Study type: Interventional

Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

NCT ID: NCT03070470 Completed - Pharmacokinetics Clinical Trials

CiPA Phase 1 ECG Biomarker Validation Study

Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with approximately equipotent late sodium and/or calcium block ("balanced ion channel" drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block hERG without late sodium or L-type calcium current block ("predominant hERG" drugs) cause QTc prolongation.

NCT ID: NCT03033394 Completed - Pharmacokinetics Clinical Trials

Beta-lactam Pharmacokinetics in Secondary Care

Start date: July 12, 2017
Phase:
Study type: Observational

Currently in the UK, TDM is routinely performed for aminoglycosides and glycopeptide antimicrobial agents, given fears over the narrow therapeutic window of these agents and the serious adverse events associated with toxicity. However, in critical care the role of TDM for optimisation of therapy has been demonstrated to help optimise dosing of patients who tend to have variable pharmacokinetic parameters (J. A. Roberts et al,). This is of growing importance given that low concentrations of antimicrobial agents, below a micro-organisms minimum inhibitory concentration (MIC) is believed to be a major driver of AMR. The investigators set out to explore whether similar observations in PK-PD target variability are currently being observed across the secondary care setting (outside of critical care) and whether these appear to be impacting on clinical outcomes.

NCT ID: NCT03012763 Completed - Pharmacokinetics Clinical Trials

Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

Start date: April 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine, given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml grapefruit juice prior to ingestion and to visualize the localization and to measure the filling volume of stomach, small intestine as well as ascending, transverse and descending colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water (non-caloric water), after administration of 240 ml caloric drink and after administration of 240 ml grapefruit juice.

NCT ID: NCT03011463 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1

Start date: November 2016
Phase: Phase 1
Study type: Interventional

The purpose of the study is: - to determine absolute bioavailability, input rates, distribution volume, renal and intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 - to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor ranitidine - to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin - to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin.

NCT ID: NCT02974361 Completed - Pharmacokinetics Clinical Trials

Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

Start date: December 2016
Phase: Phase 1
Study type: Interventional

This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen. This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively. A total of 30 subjects will take part in the study; 10 per study part. The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.