Clinical trials: Pharmacokinetic Study
Bone Infection, Joint Infection
Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections
Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease Society of America. However, most of studies did not investigate daptomycin pharmacokinetics in this indication while it is known that…
- Trial name
- NCT03134521
- Volunteers
- 189 people
- Sponsor
- Hospices Civils de Lyon
Bone and Joint Infection, Patient Treated by Daptomycin
Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections
Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society…
- Trial name
- NCT03209921
- Volunteers
- 23 people
- Sponsor
- Hospices Civils de Lyon
Children With Confirmed HIV Infection, Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose
Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra
Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB treatment.
- Conditions
- Children With Confirmed HIV Infection, Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose, Successfully Completed TB Treatment in the Past 2 to 6 Weeks of Enrollment
- Trial name
- RBT (NCT01259219)
- Testing
- Mycobutin
- Where
- 3 sites in South Africa
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Harriet Shezi Children's Clinic
Nonalcoholic Steatohepatitis
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods.
- Trial name
- NCT05983328
- Testing
- HUYPS-1 one tablet, HUYPS-1 nine tablets
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Prostatic Neoplasms
Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
- Trial name
- NCT00137436
- Testing
- Docetaxel, Prednisone, SU011248
- Where
- 24 sites in United States
- Volunteers
- 93 people
- Sponsor
- Pfizer
Hepatocellular Carcinoma (HCC)
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.
- Trial name
- NCT03516071
- Testing
- Brivanib 800 mg, QD, Brivanib 400 mg, BID
- Where
- 15 sites in China
- Volunteers
- 90 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Hypertension
CKD-828(80/2.5mg) Pharmacokinetic Study
The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
- Trial name
- NCT01246193
- Testing
- CKD-828(FDC), Combination Therapy
- Where
- South Korea
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Opioid Overdose
Naloxone Nasal Spray Pharmacokinetic Study
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization…
- Trial name
- NCT01622504
- Testing
- MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Mitovie Pharma Ltd
Pulmonary Disease, Chronic Obstructive
Study of GSK961081 in Healthy Volunteer Subjects
GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic obstructive pulmonary disease (COPD). This study is the first clinical study in humans.
- Trial name
- NCT00887406
- Testing
- GSK961081 15mcg SD, GSK961081 3mcg SD, GSK961081 50mcg SD
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
FDC, Diabetes Mellitus, Type 2
To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination
To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.
- Trial name
- NCT05737771
- Testing
- DWC202213, DWJ1563, DWP16001
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Healthy
Safety and Tolerability of Lu AG06474 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
- Trial name
- NCT05003687
- Testing
- Lu AG06474
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Epilepsy in Pregnancy
Pharmacokinetic and Placental Transfer of Levetiracetam
Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand.
- Trial name
- EPICEINTE (NCT04117425)
- Testing
- biological collection
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Obesity
Dexmedetomidine Pharmacokinetics in the Obese
The aim of this study is to characterize, using two different modeling approaches, one based on purely statistic concept and one using a more mechanistic analysis, the influence of body weight and composition on the…
- Trial name
- NCT02187068
- Testing
- Dexmedetomidine
- Where
- Chile
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Breast Cancer
Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule.
- Trial name
- NCT02833155
- Testing
- Entinostat, Exemestane
- Where
- 4 sites in China
- Volunteers
- 19 people
- Sponsor
- Taizhou EOC Pharma Co., Ltd.
Chemotherapy-induced Neutropenia
A Safety and PK Study of EC-18 in Healthy Subjects
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
- Trial name
- NCT02496143
- Testing
- EC-18
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Enzychem Lifesciences Corporation
Advanced Solid Tumors
Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
The research project is testing this potential new medication for advanced solid tumours. This research project is being done to get more information about the study drug (XNW7201).
- Trial name
- NCT03901950
- Testing
- XNW7201 tablets
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Evopoint Biosciences Inc.
Hepatic Function Abnormal
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat.
- Trial name
- NCT05718258
- Testing
- Venglustat (GZ402671)
- Where
- 6 sites in United States, Germany
- Volunteers
- 26 people
- Sponsor
- Sanofi