Clinical trials: Pharmacology, Clinical
Diabetic Foot Ulcers
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
- Trial name
- NCT04945161
- Testing
- ON101 Cream
- Where
- Taiwan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oneness Biotech Co., Ltd.
Clinical Pharmacology, Healthy Volunteer Study
A Phase 1 QT Study in Healthy Male Subjects
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval.
- Trial name
- QT/QTc (NCT01986894)
- Testing
- Pomalidomide, Moxifloxacin
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Celgene
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
Pharmacology, Clinical
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose of 10 mg Immediate Release Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure).
- Trial name
- NCT04320771
- Testing
- Neladenoson bialanate (BAY 1067197)
- Where
- 2 sites in Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Clinical Pharmacology
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
- Trial name
- NCT03136666
- Testing
- Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Pharmacology, Clinical
Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.
- Trial name
- NCT01044524
- Testing
- SLV 334
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Solvay Pharmaceuticals
Clinical Pharmacology, Healthy Male Volunteer Study
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that…
- Trial name
- NCT02049528
- Testing
- CC-122
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Renal Impairment
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.
To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.
- Trial name
- NCT02048787
- Testing
- Buparlisib
- Where
- 4 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Clinical Pharmacology
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2…
- Trial name
- NCT03424135
- Testing
- Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety…
- Trial name
- NCT04481789
- Testing
- MT-1186, Rosuvastatin, Sildenafil
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Controls
Pomaglumetad Effects on Glutamate Biomarkers
The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also…
- Trial name
- NCT02919774
- Testing
- POMA
- Where
- 4 sites in United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Healthy
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates
This study consisted of 2 parts: Part 1 and 2. The purpose of this study was to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in…
- Trial name
- NCT05064488
- Testing
- Evobrutinib (45mg), Digoxin (0.25mg), Metformin (10mg)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
HIV
Effect of Gender and HIV Infection on Zidovudine and Lamivudine Pharmacokinetics
This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection.
- Trial name
- NCT01386970
- Testing
- zidovudine 300mg and lamivudine 150mg as Combivir
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Pharmacology, Clinical
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting…
- Trial name
- Orca (NCT03929861)
- Testing
- Fluconazole (BAYT006267) 150 mg capsules, Fluconazole 150 mg capsules (DiflucanTM)
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Premenopause
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been…
- Trial name
- NCT00628121
- Testing
- Cetrorelix
- Where
- Japan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Nippon Kayaku Co., Ltd.
Prediabetic State, Dysglycemia
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk
This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day, on cardiometabolic health and gut microbiota profile in overweight-obese…
- Conditions
- Prediabetic State, Dysglycemia, Overweight and Obesity
- Trial name
- NCT05369585
- Testing
- TOTUM-63
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Healthy
Clinical Pharmacology of FYU-981 (Final Formulation)
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted…
- Trial name
- NCT03350373
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Breast Feeding, Human Milk
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake.
- Trial name
- UmbrelLACT (NCT06042803)
- Testing
- Human milk collection, Optionally: maternal blood sample, Optionally: child blood sample
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Scientific Collaboration in Clinical Pharmacology
Where Did the Authors Work When They Conducted Their Clinical Pharmacology Studies?
It is unknown in which countries the clinical pharmacology studies published in leading specialized journals were conducted. The hypothesis is that studies in this specialty tend to be conducted and published by authors from a…
- Trial name
- NCT07115680
- Testing
- human participants, data or material
- Where
- Spain
- Volunteers
- 503 people, healthy volunteers welcome
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz