Clinical trials: Drug Dose
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Malignant Glioma, Glioblastoma
Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma.
- Trial name
- NCT02330562
- Testing
- MRZ, BEV
- Where
- 5 sites in United States, Canada
- Volunteers
- 121 people
- Sponsor
- Celgene
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
- Trial name
- NCT02413255
- Testing
- TAK-020
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Takeda
Acute Pain
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
- Trial name
- NCT04622735
- Testing
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, Nefopam HCl 30 MG Oral Tablet X2
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 321 people
- Sponsor
- Unither Pharmaceuticals, France
Obesity
PK/PD of High Dose Pip/Tazo in Obese Patients
Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients.
- Trial name
- NCT01923363
- Testing
- Piperacillin/Tazobactam Standard Dose to High Dose
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Loma Linda University
Huntington Disease
Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test doses of Cellavita HD product.
- Trial name
- ADORE-DH (NCT03252535)
- Testing
- Cellavita HD lower dose, Cellavita HD higher dose
- Where
- Brazil
- Volunteers
- 49 people
- Sponsor
- Azidus Brasil
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Drug-induced Surface ECG Changes
Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their effects on electrophysiological and other clinical parameters.
- Trial name
- NCT01873950
- Testing
- Ranolazine, Dofetilide, Verapamil
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Mucopolysaccharidosis Type 7
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the…
- Trial name
- NCT01856218
- Testing
- UX003
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Peanut Allergy
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
The objectives of this dose-finding study for the treatment of peanut allergy are: To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize…
- Trial name
- VIPES (NCT01675882)
- Testing
- Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, Viaskin Peanut 250 mcg
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 221 people
- Sponsor
- DBV Technologies
Schizophrenia
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
- Trial name
- NCT00044044
- Testing
- Lurasidone 20 mg, Lurasidone 40mg, Lurasidone 80 mg
- Where
- 34 sites in United States
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.
Rheumatoid Arthritis
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
- Trial name
- NCT05437419
- Testing
- TCK-276
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Teijin America, Inc.
Diabetes Mellitus
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT01890122
- Testing
- Alogliptin, Metformin HCl, Alogliptin and Metformin Fixed-Dose Combination (FDC)
- Where
- 45 sites in China, Malaysia and 2 more
- Volunteers
- 647 people
- Sponsor
- Takeda
Major Depressive Disorder
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects.
- Trial name
- NCT00952653
- Testing
- Desvenlafaxine Succinate Sustained Release, Midazolam
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.
- Trial name
- NCT02848001
- Testing
- CC-90009
- Where
- 20 sites in United States, Canada and 4 more
- Volunteers
- 101 people
- Sponsor
- Celgene
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Major Depressive Disorder
Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder
The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).
- Trial name
- NCT02972632
- Testing
- Vortioxetine
- Where
- 25 sites in United States
- Volunteers
- 123 people
- Sponsor
- Takeda
Chronic Obstructive Pulmonary Disease
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in…
- Trial name
- NCT02951312
- Testing
- Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, Glycopyrrolate Inhalation Solution 200mg
- Volunteers
- 12 people
- Sponsor
- Sunovion Respiratory Development Inc.