Clinical trials: Pharmacokinetics
Healthy Volunteers, Safety
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose or multiple doses of RCS-21 and their health status will be constantly…
- Conditions
- Healthy Volunteers, Safety, Tolerability, Pharmacokinetics
- Trial name
- AMIR-21 (NCT06752122)
- Testing
- RCS-21 (SAD), RCS-21 (MD)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- RNATICS GmbH
NAD+ Metabolism, Pharmacokinetics
Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
This Phase 1 study is designed to evaluate the pharmacokinetic, pharmacodynamic, bioavailability, safety, and tolerability effects of trigonelline monohydrate in generally healthy adults aged 40 to 70 years.
- Conditions
- NAD+ Metabolism, Pharmacokinetics, Bioavailability, Healthy Adults
- Trial name
- NCT07880925
- Testing
- Nicotinamide Mononucleotide (NMN), Trigonelline Monohydrate
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Safety, Tolerability
A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B07) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetic
- Trial name
- NCT07878481
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pharmacokinetics and Pharmacodynamics
Comparison of the Pharmacokinetic (PK) and Pharmacodynamic (PD) Biosimilarity of Insulin Aspart 30 Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN 30® (test product) and NovoMix®30 (reference product) in healthy male participants.
- Trial name
- NCT07875803
- Testing
- Insulin Aspart 30 Injection (UBLIN 30®)), Insulin Aspart 30 Injection ( NovoMix®30)
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Pharmacokinetic Analysis
An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers
This study will assess the pharmacokinetics (PKs), safety and tolerability of ASP-001 in healthy volunteers. ASP-001 is an orally disintegrating tablet (ODT) formulation of flunarizine.
- Trial name
- NCT07445464
- Testing
- Flunarizine
- Where
- Australia
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Aspartes Pharmaceuticals, Inc.
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Healthy, Pharmacokinetic Profile
A Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure
The goal of this clinical trial is to determine the translation of propylene glycol (PG) exposure in beverages to circulating PG levels to better understand the margin of safety in healthy participants.
- Conditions
- Healthy, Pharmacokinetic Profile, Propylene Glycol
- Trial name
- NCT07644169
- Testing
- Propylene glycol
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- American Beverage Association
Remimazolam, Pharmacokinetics and Pharmacodynamics
Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult…
- Trial name
- NCT07675850
- Testing
- Eleveld model-guided dosing, Standard weight-based label dosing
- Where
- South Korea
- Volunteers
- 68 people
- Sponsor
- Seoul National University Hospital
To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic Function
A Pharmacokinetic Study of HS-10504 in Participants With Hepatic Impairment and Normal Hepatic Function.
This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function.
- Trial name
- NCT07836504
- Testing
- HS-10504
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Pharmacokinetics
Pharmacokinetics and Pharmacodynamics of Sugammadex Dosed by Corrected Body Weight for Reversal of Vecuronium in Obese Patients
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery
- Trial name
- NCT05328778
- Testing
- Sugammadex
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Guangzhou General Hospital of Guangzhou Military Command
Pharmacokinetics, Amoxicillin-clavulanate
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
- Conditions
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- Trial name
- PADECMO (NCT06426836)
- Testing
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- Where
- 3 sites in Belgium
- Volunteers
- 300 people
- Sponsor
- University Hospital, Ghent
Pharmacokinetics, Amoxicillin-clavulanate
Antibiotic Dosing in Pediatric Intensive Care
Pharmacokinetics of antibiotics in critically ill neonates, infants and children
- Conditions
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Vancomycin
- Trial name
- ADIC (NCT02456974)
- Testing
- blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care, blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care., blood sampling in patients receiving vancomycin as part of routine clinical care.
- Where
- Belgium
- Volunteers
- 640 people
- Sponsor
- University Hospital, Ghent
Pharmacokinetic Study in Healthy Volunteers
Evaluation of Solanidine as an Exogenous Biomarker to Phenotype CYP2D6 Activity in Humans
This study investigates the evaluation of solanidine as an exogenous biomarker to phenotype CYP2D6-activity in humans. Participants will be classified by their CYP2D6 genotype into poor metabolizers (PM), low intermediate…
- Trial name
- SOLA-1 (NCT07817030)
- Testing
- Yohimbine, Consumption of a defined potato-rich meal
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald
Linezolid Pharmacokinetics in Young Infants, Pharmacokinetic Analysis
Oral Antibiotic Pharmacokinetics in Young Infants
This observational study will characterize the pharmacokinetics of linezolid in young infants. Participants will receive linezolid either as part of routine clinical care or as a single, one-time study dose.
- Conditions
- Linezolid Pharmacokinetics in Young Infants, Pharmacokinetic Analysis, Linezolid, Infant and Young Children
- Trial name
- NCT07815613
- Testing
- Linezolid (LZD)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Colorado, Denver
Healthy Participants, Pharmacokinetic Study
An Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
- Trial name
- ATLAS (NCT07361354)
- Testing
- AGA2118
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Angitia Incorporated Limited
Tenofovir, Tenofovir Alafenamide Fumarate
Tenofovir Exposures in Advanced Kidney Disease Study
Phamacokinetic study to evaluate tenofovir, emtricitabine and tenofovir alafenamide exposures in people with HIV who have chronic kidney disease stage 4 (estimated glomerular filtration rate [eGFR] 15-29 mL/min/1.73m2) or stage 3…
- Conditions
- Tenofovir, Tenofovir Alafenamide Fumarate, Chronic Kidney Diease, Kidney Failure
- Trial name
- TEAK (NCT07812571)
- Testing
- Plasma sampling for tenofovir and emtricitabine, Descovy
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- King's College Hospital NHS Trust
Cetuximab, Bioequivalence
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects
- Conditions
- Cetuximab, Bioequivalence, Healthy Volunteers, Pharmacokinetics
- Trial name
- BT-HC034S-101 (NCT07813468)
- Testing
- HC034S, Erbitux (Cetuximab)
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
Abuse Cannabis, Pain
High Potency Cannabis: Acute and Protracted Effects
The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
- Conditions
- Abuse Cannabis, Pain, Pharmacokinetics
- Trial name
- HIGH-CAP (NCT06859723)
- Testing
- Low dose THC, High dose THC
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Herb-Herb Interaction, Pharmacokinetics
Pharmacokinetics of Kava and Kratom Alone and in Combination
This study is being conducted to evaluate how different formulations of the Feel Free® Tonic containing Kava, Kratom, or a combination of both are processed in the body in healthy adults.
- Trial name
- NCT07583407
- Testing
- Kava and Kratom Herbal Supplement, Kava Herbal Supplement, Kratom Herbal Supplement
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Botanic Tonics, LLC