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Pharmacokinetics clinical trials

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NCT ID: NCT04759768 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Evaluation of Intranasal Nalmefene

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.

NCT ID: NCT04684381 Completed - Sickle Cell Disease Clinical Trials

Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients

Start date: January 4, 2021
Phase: Phase 4
Study type: Interventional

L-glutamine has been approved in the US to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. The purpose of this single-center, open-label, phase 4 study is to evaluate the pharmacokinetic characteristics and safety of L-glutamine in patients with SCD.

NCT ID: NCT04668274 Completed - Pharmacokinetics Clinical Trials

JOTROL PK, Safety, and Food Effect Assessment

Start date: January 21, 2021
Phase: Phase 1
Study type: Interventional

Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg, in healthy subjects. To evaluate the safety and tolerability of JOTROL To evaluate the effect of food on the PK profile of JOTROL. Study Design: Phase I, randomized, open-label, sequential SAD study with a food effect evaluation. Blood plasma and urine samples will be assessed for resveratrol and key metabolite content. Type of Control: No control Test Product: JOTROL (resveratrol) 100 mg resveratrol in 1000 mg softgel capsule for oral administration Dosage Regimen: Planned dose levels of resveratrol: 200 mg, 500 mg, and 1,000 mg. Following completion of each dose level, PK, safety, and tolerability data will be evaluated; dose levels may be adjusted. Route of Administration: Oral gelcaps with water Number of Subjects: 24 subjects will be included in Part 1; only 16 subjects, who completed Part 1, will be included in Part 2. Subjects: Healthy, non-smoker, adult males or females, ≥ 18 and ≤ 75 years of age Study Duration: Participation of each subject in this study should last approximately 1 to 1.5 months (for subjects participating in study Part 1 only) and 1.5 to 2 months (for subjects participating in both study parts).

NCT ID: NCT04631874 Completed - Smoking Cessation Clinical Trials

A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"

Start date: July 24, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers

NCT ID: NCT04565145 Completed - Pharmacokinetics Clinical Trials

Biomarker Changes and Anxiolytic Effects-Phase 2

KavaPK
Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.

NCT ID: NCT04501250 Completed - Pharmacokinetics Clinical Trials

Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using the euglycemic hyperinsulinemic clamp.

NCT ID: NCT04459598 Completed - Healthy Subjects Clinical Trials

A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants

Start date: August 19, 2020
Phase: Phase 1
Study type: Interventional

This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.

NCT ID: NCT04459585 Completed - Healthy Subjects Clinical Trials

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

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

The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.

NCT ID: NCT04435483 Completed - Pharmacokinetics Clinical Trials

A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers

Start date: May 22, 2020
Phase: Phase 1
Study type: Interventional

This study is being conducted to support the clinical development of acalabrutinib in patients who are unable to swallow capsule and require nasogastric (NG) tube placement.

NCT ID: NCT04406415 Completed - Pharmacokinetics Clinical Trials

Oral Nafamostat in Healthy Volunteers

Start date: September 21, 2020
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects