Clinical trials: Pharmacokinetic Study
Healthy
Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
This is the first time finafloxacin was administered to humans intravenously. The principal aim of this study was to obtain safety and tolerability data when finafloxacin was administered intravenously as single and multiple…
- Trial name
- NCT01910883
- Testing
- Finafloxacin i.v. solution 200 mg, Finafloxacin i.v. solution 400 mg, Finafloxacin i.v. solution 600 mg
- Where
- United Kingdom
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- MerLion Pharmaceuticals GmbH
Hearing Loss, Sensorineural Hearing Loss
Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to…
- Conditions
- Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Loss
- Trial name
- NCT02259595
- Testing
- HPN-07, NAC
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otologic Pharmaceutics, Inc.
NASH - Nonalcoholic Steatohepatitis
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.
- Trial name
- NCT04808154
- Testing
- SNP-630
- Where
- Taiwan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Hypoactive Sexual Desire Disorder
A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®
The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
- Trial name
- NCT01096329
- Testing
- Testosterone Spray 5% and 1%, Intrinsa® Patch and Testosterone Spray 5%, Intrinsa® Patch and Testosterone Spray 1%
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Pharmacokinetics, Bioavailability
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005…
- Trial name
- NCT05967377
- Testing
- Sorafenib - Period 1, XS005 Sorafenib Capsule A - Period 1, XS005 Sorafenib Tablet A - Period 1
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Xspray Pharma AB
Atopic Dermatitis
A First-in-Human Study of QY211 Gel in Adult Subjects
This is a phase Ia/Ib,Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Single and Multiple Topical Doses of…
- Trial name
- NCT05843422
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
Healthy Adult Volunteers
Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I
- Trial name
- NCT02058472
- Testing
- G3041, SEVIKAR®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dong-A Pharmaceutical Co., Ltd.
Safety and Pharmacokinetics of Intravenous Ascorbate
Evaluation of Intravenous Ascorbic Acid
This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by evaluation in oncology subjects.
- Trial name
- NCT01833351
- Testing
- IV Vitamin C
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Pulmonary Fibrosis, Tumor
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
- Trial name
- NCT05740475
- Testing
- 9MW3811 injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Healthy
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
The purpose of this study was to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this…
- Trial name
- NCT02189941
- Testing
- Deferiprone sustained-release, Deferiprone immediate-release
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Advanced Non-small Cell Lung Cancer
Pharmacokinetic Study of HS-10241 Tablets in Subjects with Hepatic Impairment and Normal Hepatic Function
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages.
- Trial name
- NCT06823245
- Testing
- HS-10241
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Study Participants, Impaired Hepatic Function
A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
The purpose of the study is to evaluate the plasma pharmacokinetic (PK), safety and tolerability of padsevonil (PSL) in hepatically impaired and non-hepatically impaired study participants.
- Trial name
- NCT04136444
- Testing
- Padsevonil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Mixed Dyslipidemia, Food Effect Study of AD-117
A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers
A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers
- Trial name
- NCT07495514
- Testing
- AD-117
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Malaria
MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B
Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum…
- Trial name
- NCT02783833
- Testing
- MMV390048 40mg, MMV390048 dose to be determined mg
- Where
- Australia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy Volunteers
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes.
- Trial name
- NCT05459857
- Testing
- Product A, Product B, Product C
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial Brands PLC
Cancer
To Assess the Interaction Between Sunitinib and Ketoconazole to Reduce the Dose and Cost of Sunitinib
Sunitinib is an ATP competitive tyrosine kinase inhibitor of several membrane receptors including VEGFR-1, -2, and -3, PDGFR-α and -β, c-KIT, CSF-1R, FLT-3, and RET.
- Trial name
- NCT01548170
- Testing
- Sunitinib, Sunitinib and Ketoconazol, Sunitiinb and Ketoconazol
- Where
- Spain
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Opioid Use Disorder
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner.
- Trial name
- NCT03810495
- Testing
- naltrexone implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Alpha-1 Antitrypsin Deficiency (AATD)
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
This study is the first study in the RestorAATion clinical program. The purpose of this first-in human (FIH), double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple-dose Phase 1 study is to assess…
- Trial name
- RestorAATion-1 (NCT06186492)
- Testing
- WVE-006
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Wave Life Sciences USA, Inc.
Healthy Subjects
Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects.
- Trial name
- NCT06160401
- Testing
- Singletine
- Where
- China
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
Healthy Subjects
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fast condition.
- Trial name
- NCT05874167
- Testing
- DW6013
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
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