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Drug Interaction clinical trials

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NCT ID: NCT03336346 Completed - HIV Infections Clinical Trials

Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana

Start date: November 15, 2017
Phase:
Study type: Observational

The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG) have a 20% or greater change in their ENG plasma levels, compared to women taking no antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking dolutegravir have significantly higher ENG plasma levels than ENG implant users taking efavirenz. This is a cross-sectional, non-randomized evaluation to compare ENG levels between 3 and 12 months post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2) women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This study will be conducted in Botswana in Southern Africa among women using the ENG implant, and involves a one-time collection of blood and questionnaire.

NCT ID: NCT03187015 Completed - Healthy Volunteer Clinical Trials

A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects

Start date: May 23, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of Midazolam. The primary objective is to evaluate the effect of a single oral dose of entinostat on the pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects. The secondary objective is to evaluate the safety and tolerability of combined administration of entinostat and midazolam in healthy subjects.

NCT ID: NCT03011996 Completed - Drug Interaction Clinical Trials

To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration

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

Cohort 1 To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects. Cohort 2 To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in combination with amoxicillin/clarithromycin in healthy subjects as compared to an active control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.

NCT ID: NCT02671097 Completed - Healthy Volunteers Clinical Trials

Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate

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

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

NCT ID: NCT02560688 Completed - Drug Interaction Clinical Trials

Phase 1 Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion With Clopidogrel in Healthy Subjects

Start date: December 2015
Phase: Phase 1
Study type: Interventional

This study is being conducted to test the hypothesis that coadministration of clopidogrel with DS-1040b will be safe and well tolerated. Subjects entering the study will initially receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects will receive repeated clopidogrel doses over 5 days to generate data on the effect of clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and the effects will be compared to when the two treatments were given alone.

NCT ID: NCT02391688 Completed - Drug Interaction Clinical Trials

Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail

Start date: November 2014
Phase: Phase 1
Study type: Interventional

Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. The administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and P-gp in a single test. When a cocktail approach is used it is important to make sure that no drug-drug interactions occur between the probes within the cocktail. The validation of the lack of interactions, which is the aim of the study, consists of demonstrating that there is no difference in the pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively. Probe and metabolite concentrations will be measured in capillary blood using a dried blood spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to ensure the precision of capillary blood collection.

NCT ID: NCT01801280 Completed - Immunosuppression Clinical Trials

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.

NCT ID: NCT01370343 Completed - Healthy Clinical Trials

Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.

NCT ID: NCT01254461 Completed - Drug Interaction Clinical Trials

A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

Start date: February 2011
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.

NCT ID: NCT01170533 Completed - Drug Interaction Clinical Trials

PPI and Clopidogrel Response

Start date: March 2009
Phase: Phase 1
Study type: Interventional

Clopidogrel, in combination with aspirin, is currently the recommended treatment for secondary prevention of ischemic events in high-risk patients and for prevention of coronary artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated with proton pump inhibitors, such as omeprazole or pantoprazole, in order to prevent the risk of gastrointestinal bleeding, accorded to guidelines. An interaction between proton pump inhibitors and clopidogrel has been suggested, which may lead to a decrease of clopidogrel effects. It remains unclear whether this interaction between PPIs and clopidogrel might be a class effect or if this may be affected by timing regimen. The objectives of this two-phase investigation are: 1. to compare clopidogrel platelet inhibitory effects when taken at the same time versus separated at least 8 hours from omeprazole administration. 2. to compare clopidogrel-induced inhibitory effects when taken at the same time versus staggered at least 8 hours from pantoprazole administration.