Clinical trials: Pharmacokinetic
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
Pharmacokinetics of Zolbetuximab, Gastric Cancer
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer).
- Conditions
- Pharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin
- Trial name
- ILUSTRO (NCT03505320)
- Testing
- zolbetuximab, oxaliplatin, leucovorin
- Where
- 21 sites in United States, France and 4 more
- Volunteers
- 143 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Busulfan Pharmacokinetic Analysis, Busulfan Dosing
26DT052; Scaling Busulfan Dose to Body Surface Area in Children
The goal of this pilot study is to determine if scaling the first busulfan dose to Body Surface Area (BSA) in children with a BSA ≥0.5 m2 and using a BSA-banded dosing table for infants (BSA <0.5 m2) increases the fraction of…
- Conditions
- Busulfan Pharmacokinetic Analysis, Busulfan Dosing, Hematopoietic Stem Cell Transplant (HSCT), Busulfan
- Trial name
- NCT07792369
- Testing
- Busulfan (BU)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Children's Hospital of Philadelphia
Drug Drug Interaction (DDI), Pharmacokinetics and Pharmacodynamics
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.
- Trial name
- NCT07785934
- Testing
- UBT251, Metformin hydrochloride, Warfarin Sodium
- Where
- China
- Volunteers
- 48 people
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
Pharmacokinetics, Healthy Volunteers
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adults (18-55 Years)
This was a Phase 1, open-label, single-center Pharmacokinetic (PK) study to evaluate plasma and intrapulmonary pharmacokinetics (PK) of ceftibuten and ledaborbactam in healthy adult participants.
- Trial name
- NCT06665555
- Testing
- ledaborbactam etzadroxil, ceftibuten
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Omega-3 Fatty Acids, Absorption of Omega-3
Study of Metabolic Absorption Rates of DHA-Taurine as a Source of Omega-3 Fatty Acids
Omega-3 fatty acids such as docosahexaenoic acid (DHA) have well-established health benefits and are widely used to improve cardiometabolic health.
- Conditions
- Omega-3 Fatty Acids, Absorption of Omega-3, Pharmacokinetics
- Trial name
- SMART (NCT07771309)
- Testing
- DHA-taurine, DHA ethyl ester
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects
Pharmacokinetic Effect of AstraGin on Whey Protein Absorption and Muscle Function in Healthy Subjects
This study gave healthy people supplements with ginseng and astragalus saponin extracts (AstraGin), combined with whey protein, to explore whether it can promote amino acid absorption and thereby enhance protein nutritional…
- Trial name
- NCT06110260
- Testing
- AstraGin (Ginseng and Astragalus Saponin Extract)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chung Shan Medical University
Healthy Participants, Pharmacokinetics
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
- Trial name
- NCT07422285
- Testing
- Evolocumab Drug Substance A, Evolocumab Drug Substance B
- Where
- 4 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Amgen
Pharmacokinetics
Safety and Pharmacokinetics (PK) Study of Natrunix in Healthy Volunteers
This trial will be a Phase I open-label, placebo-controlled dose escalation study to evaluate safety and pharmacokinetics of Natrunix via subcutaneous injection in healthy subjects.
- Trial name
- NCT05099510
- Testing
- Natrunix
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- XBiotech, Inc.
Pharmacokinetics and Pharmacodynamics
Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN® (test product) and NovoRapid® (reference product) in healthy male participants.
- Trial name
- NCT07600944
- Testing
- Insulin Aspart Injection（UBLIN®）, Insulin Aspart Injection（NovoRapid®）
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
- Trial name
- NCT04220073
- Testing
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Kratom Pharmacodynamics, Kratom Pharmacokinetics
Preliminary Characterization of Commercial Kratom Extract Products
To understand the acute subjective, physiological, and cognitive effects of commercial kratom extract products among US adults who consume these products regularly, and to understand how these products are metabolized by the…
- Trial name
- NCT06640569
- Where
- 2 sites in United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Pregnancy, Pharmacokinetics
Pharmacokinetics of Oral Calcium Carbonate in Parturients
This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums").
- Conditions
- Pregnancy, Pharmacokinetics, Postpartum Hemorrhage
- Trial name
- NCT06650930
- Testing
- Oral calcium carbonate, Oral calcium citrate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanford University
Obesity & Overweight, Bariatric Surgery
Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery
This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan.
- Conditions
- Obesity & Overweight, Bariatric Surgery, Pharmacokinetics After Oral Intake, Drug Absorption
- Trial name
- BARI-PK (NCT07748273)
- Testing
- Rosuvastatin, Losartan (Control)
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Hospital das Clínicas de Ribeirão Preto
Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
Pharmacokinetics, Pharmacodynamics, and Safety of NANOKINE Compared With Eprex 4000 U in Healthy Volunteers
This clinical trial aims to compare the pharmacokinetic (PK), pharmacodynamic (PD) parameters, and safety between Nanokine of Nanogen Pharmaceutical Joint Stock Company and Eprex® of Janssen Cilag Ltd on healthy male volunteers.
- Trial name
- NCT06919861
- Testing
- Erythropoietin alfa
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Safety, Tolerability
A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B01) 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, Pharmacokinetics
- Trial name
- NCT07285967
- 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
Pharmacokinetics, Neurology
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers.
- Trial name
- NCT06921590
- Testing
- AL001, Lithium Carbonate Capsule
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alzamend Neuro, Inc.
Drug Drug Interaction, Pharmacokinetic Profiles
Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants
The primary objective of this study is to evaluate the effect of Y-3 for injection on the pharmacokinetics of rosuvastatin calcium tablets (a sensitive BCRP probe substrate) in healthy participants, in order to assess the…
- Conditions
- Drug Drug Interaction, Pharmacokinetic Profiles, Safty
- Trial name
- NCT07692685
- Testing
- Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Neurodawn Pharmaceutical Co., Ltd.
Pharmacokinetics, Pharmacodynamics
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of…
- Conditions
- Pharmacokinetics, Pharmacodynamics, Insulin Aspart
- Trial name
- NCT07560150
- Testing
- I004, NovoLog
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Pharmacokinetics
To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.
Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects
- Trial name
- NCT07703904
- Testing
- Hemay5259 group 1, Hemay5259 group 2
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hemay Pharmaceutical PTY. LTD.