Clinical trials: Evaluate PK Profile
Postoperative Pain
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing…
- Trial name
- NCT00728832
- Testing
- DepoDur (extended-release epidural morphine)
- Volunteers
- 39 people
- Sponsor
- EKR Therapeutics, Inc
Healthy
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.
- Trial name
- NCT03830463
- Testing
- CTP-692
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Gram Positive Infection, Concurrent Antibiotic Treatment
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a…
- Trial name
- NCT00679835
- Testing
- daptomycin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Pharmacokinetics
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable).
- Trial name
- NCT05232461
- Testing
- PrimeC-ER 748 mg, Ciprofloxacin 750 MG, Celecoxib 200mg
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NeuroSense Therapeutics Ltd.
Healthy Subjects
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single…
- Trial name
- NCT03279302
- Testing
- Glepaglutide
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Hyperammonemia
A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules
The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokinetics.
- Trial name
- NCT06178718
- Testing
- TNP-2092 capsules
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Healthy
Effect of Food Intake on Pharmacokinetic Profiles of Z-338
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.
- Trial name
- NCT00920998
- Testing
- Z-338
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Gout, Hyperuricemia
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
- Trial name
- NCT06678581
- Testing
- SAP-001
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Co., Ltd.
Healthy Chinese Volunteers
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
- Trial name
- NCT03610867
- Testing
- Furaprevir capsule (SAD), Furaprevir capsule (MAD)
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer, Melanoma
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs.
- Conditions
- Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma
- Trial name
- NCT07160335
- Testing
- HLX17, US-sourced Keytruda®
- Where
- 69 sites in United States, China and 2 more
- Volunteers
- 174 people
- Sponsor
- Shanghai Henlius Biotech
Evaluate PK Profile
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
- Trial name
- PK/ADA (NCT04840849)
- Testing
- nirsevimab
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bacterial Infections
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
- Trial name
- NCT02688790
- Testing
- Dalbavancin
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- AbbVie
Overweight or Obesity
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
- Trial name
- NCT06973681
- Testing
- BGM0504
- Where
- China
- Volunteers
- 120 people
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
Healthy, Multiple Sclerosis
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers…
- Trial name
- NCT01610310
- Testing
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Biogen
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Healthy Chinese Volunteers
To Evaluate PK and Safety Profile of Oral MAD of Separately Using TG-2349, DAG181 or Combination in Healthy Chinese Volunteers
To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.
- Trial name
- NCT03610880
- Testing
- TG-2349 (400 mg) plus DAG181 (200 mg), DAG181 (200 mg) plus TG-2349 (400 mg)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Healthy
Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin
The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic…
- Trial name
- NCT01992211
- Testing
- Rosuvastatin, Metformin, BCWP_C003
- Where
- South Korea
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- BC World Pharm Co. Ltd.
Asthma
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the…
- Trial name
- NCT01737892
- Testing
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Plaque Psoriasis
Treatment of Moderate to Severe Plaque Psoriasis
To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses
- Trial name
- NCT06542614
- Testing
- TQH3906 capsules
- Where
- 35 sites in China
- Volunteers
- 209 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.