Clinical trials: Pharmacokinetic Study
Healthy
A Safety, Tolerability, PD and PK Study in Healthy Adults
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
- Trial name
- NCT02211625
- Testing
- Open-label TRV734 125 mg, TRV734 blinded, Oxycodone IR 10 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Trevena Inc.
Lipoma, Submental Fullness
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of…
- Trial name
- NCT07237425
- Testing
- Ronkyla Plus, Kybella
- Where
- 3 sites in Taiwan
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Glonova Pharma Co., Ltd
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Hemophilia B
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B
The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time.
- Trial name
- NCT01233440
- Testing
- Recombinant Coagulation Factor IX Albumin Fusion Protein, Plasma derived FIX [pdFIX]
- Where
- 20 sites in Austria, France and 4 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Parkinson Disease
WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
- Trial name
- NCT04513340
- Testing
- WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS
- Where
- India
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited
Type 2 Diabetes Mellitus
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
- Trial name
- NCT06492655
- Testing
- CKD-383(Fed), CKD-383(Fasted)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Healthy
Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control.
- Trial name
- NCT02217826
- Testing
- DG3173, Saline, Octreotide
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Aspireo Pharmaceuticals Limited
Neoplasms
A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm.
- Trial name
- NCT03416335
- Testing
- DSP-0509, DSP-0509, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sumitomo Pharma America, Inc.
ADVANCED SOLID TUMORS
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
- Trial name
- NCT00877474
- Testing
- PM01183
- Where
- 2 sites in United States, Spain
- Volunteers
- 30 people
- Sponsor
- PharmaMar
Asthma
A Clinical Trial of TQC2938 Injection in Healthy Adult Subjects
The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic…
- Trial name
- NCT06449859
- Testing
- TQC2938 Injection
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Healthy Volunteers, Pharmacokinetics/Dynamics Study
A Short Term Pharmacokinetic, Pharmacodynamic and Tolerability Study to Compare AOP200704 vs. Esmolol
Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs…
- Trial name
- NCT01313143
- Testing
- AOP200704, Esmolol hydrochloride, infusion
- Where
- Czechia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AOP Orphan Pharmaceuticals AG
Healthy Participants
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants
This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B.
- Trial name
- NCT06491550
- Testing
- AZD4144- Part A, AZD4144- Part B, Rosuvastatin and Furosemide- Part C
- Where
- 2 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pain
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects
To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference)…
- Trial name
- NCT03396250
- Testing
- Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Atherosclerosis
A Healthy Volunteer Pharmacokinetic Study of Single and Repeat Doses of SB-480848
This study is designed to assess the pharmacokinetics of darapladib and its metabolites following single and 28 days of repeat dosing of darapladib.
- Trial name
- NCT00743860
- Testing
- darapladib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Smoking, Tobacco
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in…
- Trial name
- NCT05789420
- Testing
- P1R stick, P1M stick, CIG
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Kidney Transplantation
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the…
- Trial name
- NCT01292226
- Testing
- mycophenolate mofetil, antibody induction, Cyclosporine
- Where
- 7 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Pain
Naproxen Sodium ER Pharmacokinetic Study
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
- Trial name
- NCT00818415
- Testing
- Naproxen sodium ER (BAYH6689), Commercial Naproxen (Aleve, BAYH6689)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Plaque Psoriasis
Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis.
- Trial name
- UNCOVER-A (NCT01777191)
- Testing
- Ixekizumab Auto-Injector, Ixekizumab Prefilled Syringe
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 204 people
- Sponsor
- Eli Lilly and Company