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Pharmacokinetics clinical trials

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NCT ID: NCT04250038 Active, not recruiting - Pharmacokinetics Clinical Trials

Association of Cefepime Trough Levels With Clinical Efficacy and Neurotoxicity in Patients With Febrile Neutropenia

Start date: August 1, 2019
Phase:
Study type: Observational

In this prospective monocenter observational study, the objective was to determine a safe and effective therapeutic window for cefepime in patients with neutropenic fever.

NCT ID: NCT04219865 Completed - Pharmacokinetics Clinical Trials

Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Start date: June 5, 2019
Phase: Phase 1
Study type: Interventional

Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers

NCT ID: NCT04207840 Completed - Asthma Clinical Trials

Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

Start date: December 9, 2019
Phase: Phase 4
Study type: Interventional

To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.

NCT ID: NCT04189484 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT ID: NCT04183517 Completed - Pharmacokinetics Clinical Trials

A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males

Start date: December 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12 subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to participate in Part B. For Part A, each of the 6 subjects will complete two periods of the study with washout period of 7 days between. Each subject during participation in the study will receive a dose of PXS 5382A orally in a fed state and a fasted state. For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state and dose will be dependent on analysis of Part A. In both part A and B PK, PD and safety assessments will be collected.

NCT ID: NCT04183491 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

Start date: February 28, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

NCT ID: NCT04183192 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT ID: NCT04181008 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

Start date: September 28, 2020
Phase: Early Phase 1
Study type: Interventional

This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride nasal spray at three different doses in healthy volunteers.

NCT ID: NCT04178629 Recruiting - Pharmacokinetics Clinical Trials

Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation (CEFTO-EVD)

CEFTO-EVD
Start date: July 2, 2019
Phase:
Study type: Observational

The Cerebrospinal fluid penetration of ceftobiprole has been studied in an animal model of meningitidis. Ceftobiprole is bactericidal, well tolerated and it has anti-biofilm activity. Altogether, these pharmacodynamics and pharmacokinetic properties of ceftobiprole are suitable for its use in case of External Ventricular Derivation(EVD)-related ventriculitis. Nowadays there are no human studies on the penetration and efficacy of ceftobiprole in the CSF. The study aims to evaluate characteristics of the CSF penetration of Ceftobiprole after intravenous administration in patients with EVD, that need for a concomitant infection this therapy (prescribed by an Infectious Diseases doctor).

NCT ID: NCT04176367 Completed - Pharmacokinetics Clinical Trials

An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA) in 2015, for the evaluation of quality and efficacy of the products manufactured in China. Related guidance was issued by Center for Drug Evaluation (CDE) on 27 Nov 2015 named "Use pharmacokinetic (PK) parameter as endpoint for chemical generics bioequivalence (BE) study". Nicergoline localized product is manufactured at Pfizer Dalian China, while the reference product is manufactured at Pfizer Italia S.r.l., Italy. The selected strength of 10 mg tablet is the marketed strength in China, and the selected dose of 30 mg (3 x 10 mg tablet) is one of the commonly used clinically approved daily doses with good tolerability profile. In each group, participants will be randomized to one of the 2 treatment sequences according to a computer generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between the first day of each period.