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Pharmacokinetics clinical trials

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NCT ID: NCT01158755 Completed - Pharmacokinetics Clinical Trials

Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years. There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.

NCT ID: NCT01131533 Recruiting - Pharmacokinetics Clinical Trials

Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Start date: January 2009
Phase: N/A
Study type: Interventional

The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.

NCT ID: NCT01124760 Completed - Pharmacokinetics Clinical Trials

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

Start date: May 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.

NCT ID: NCT01121926 Completed - Healthy Subjects Clinical Trials

A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State

Start date: January 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

NCT ID: NCT01118702 Completed - Pharmacokinetics Clinical Trials

A Study to Explore Plasma Levels of CONCERTA, Ritalin-SR and Novo-Methylphenidate ER-C in Healthy Volunteers

Start date: May 2010
Phase: Phase 1
Study type: Interventional

This is a study of blood plasma levels of methylphenidate in healthy volunteers over a 24 hour period after they take this medication.

NCT ID: NCT01086813 Withdrawn - Pharmacokinetics Clinical Trials

Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043

AZD3043
Start date: March 2010
Phase: Phase 1
Study type: Interventional

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers

NCT ID: NCT01084278 Completed - Pharmacokinetics Clinical Trials

Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)

Start date: May 2010
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.

NCT ID: NCT01082146 Completed - Pharmacokinetics Clinical Trials

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Start date: August 2008
Phase: Phase 1
Study type: Interventional

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

NCT ID: NCT01081353 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

Start date: February 2010
Phase: Phase 1
Study type: Interventional

To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects

NCT ID: NCT01072604 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

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

To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects