Clinical trials: Drug Dose
Asthma
Roflumilast Plus Montelukast in Adults With Severe Asthma
This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).
- Trial name
- NCT01765192
- Testing
- Roflumilast, Montelukast
- Where
- 13 sites in Germany, Hungary and 1 more
- Volunteers
- 64 people
- Sponsor
- AstraZeneca
Critical Limb Ischemia
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.
- Trial name
- NCT03680105
- Testing
- RJX
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Reven Pharmaceuticals, Inc.
Non-small Cell Lung Cancer, Pancreatic Cancer
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under…
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT04803305
- Testing
- PF-06946860
- Where
- 33 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Pfizer
Major Depressive Disorder With Suicidal Ideation With Intent
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent
- Trial name
- NCT04722666
- Testing
- MIJ821 Intravenous Injection
- Where
- 39 sites in United States, Argentina and 12 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834795
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Solid Tumors
Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.
- Trial name
- NCT00424632
- Testing
- PF-03814735
- Where
- 2 sites in United States, Belgium
- Volunteers
- 57 people
- Sponsor
- Pfizer
Cystinuria
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria
The purpose of this study is to evaluate the effect of escalating doses of cystine biding thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which is a measure of the amount of cystine in the…
- Trial name
- NCT02125721
- Testing
- Tiopronin 1g per day, Tiopronin 2g per day, Tiopronin 3g per day
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- NYU Langone Health
Colitis, Ulcerative, Crohn Disease
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
- Trial name
- NCT03329209
- Testing
- Vedolizumab
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Takeda
Chronic Kidney Disease Stages 3-5
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney…
- Trial name
- EASY (NCT01263028)
- Testing
- Ergocalciferol supplementation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Kaiser Permanente
Hypertension
Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions
The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ) (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and hepatic cirrhosis with ascites and edema.
- Trial name
- NCT03031496
- Testing
- GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets), Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Metastatic Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma
MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma
- Trial name
- CD205SHUTTLE (NCT03403725)
- Testing
- MEN1309
- Where
- 7 sites in Belgium, Italy and 2 more
- Volunteers
- 28 people
- Sponsor
- Menarini Group
Obesity, Tuberculosis
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol.
- Trial name
- NCT01048697
- Testing
- Ethambutol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Type 2 Diabetes Mellitus
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
- Trial name
- NCT00541450
- Testing
- Comparator: sitagliptin phosphate (sitagliptin), sitagliptin phosphate (+) metformin hydrochloride, Comparator: pioglitazone
- Volunteers
- 492 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.
- Trial name
- NCT00957268
- Testing
- Alogliptin
- Where
- 7 sites in United States
- Volunteers
- 46 people
- Sponsor
- Takeda
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A…
- Trial name
- NCT04600505
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Relapsed/Refractory, Multiple Myeloma
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone…
- Trial name
- NCT03439280
- Testing
- Mezagitamab, Pomalidomide, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Bioavailability
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
- Trial name
- NCT02064907
- Testing
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare