Clinical trials: FDC
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HER2-positive Breast Cancer
An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human…
- Trial name
- NCT04395508
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
- Where
- 12 sites in United States
- Sponsor
- Genentech, Inc.
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124573
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Hematologic Neoplasms
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with…
- Trial name
- NCT02061761
- Testing
- BMS-986016, BMS-936558
- Where
- 10 sites in United States, Canada
- Volunteers
- 106 people
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes Mellitus (T2DM)
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with…
- Trial name
- NCT06327815
- Testing
- Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, Dapagliflozin tablets and Metformin HCl extended-release tablets
- Where
- 35 sites in China
- Volunteers
- 633 people
- Sponsor
- AstraZeneca
HIV-1, HIV Infections
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral…
- Conditions
- HIV-1, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01968551
- Testing
- E/C/F/TAF, DRV, Baseline DRV- containing ARV regimen
- Where
- 62 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Gilead Sciences
Lamin A/C Gene Mutation, Dilated Cardiomyopathy, Familial
The Deep Phenotype of Lamin A/C Cardiomyopathy
This study seeks to discover clinically useful tests to improve the diagnosis of a rare and serious heart muscle disease caused by mutations in a gene called 'Lamin'.
- Trial name
- NCT03860454
- Where
- 6 sites in United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University College, London
Renal Cell Carcinoma
Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer
The NESCIO-trial is a multicenter, randomized, open-label, three-arm phase II trial investigating different combinations of neoadjuvant immunotherapy in patients with primary, resectable, intermediate to high-risk, clear-cell…
- Trial name
- NESCIO (NCT05148546)
- Testing
- Neoadjuvant nivolumab, Neoadjuvant ipilimumab, Neoadjuvant relatlimab
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 69 people
- Sponsor
- The Netherlands Cancer Institute
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
HIV-1 Infection
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination…
- Trial name
- NCT03405935
- Testing
- B/F/TAF
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 86 people
- Sponsor
- Gilead Sciences
HEPATITIS C VIRUS CHRONIC INFECTION
C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
- Trial name
- NCT06868264
- Testing
- Bemnifosbuvir-Ruzasvir (BEM/RZR), Sofosbuvir-Velpatasvir (SOF/VEL)
- Where
- 105 sites in United States, Canada
- Volunteers
- 880 people
- Sponsor
- Atea Pharmaceuticals, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)
The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg versus co-administration of the separate…
- Trial name
- NCT02741557
- Testing
- DTG, RPV, DTG/RPV FDC
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
- Conditions
- Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer
- Trial name
- NCT03538028
- Testing
- INCAGN02385
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Incyte Biosciences International Sàrl
Melanoma
Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting
The main goal of this study is to evaluate the antitumor activity of relatlimab and nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy.
- Trial name
- NCT03743766
- Testing
- Relatlimab, Nivolumab, Relatlimab + Nivolumab
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- John Kirkwood
HIV-1-infection
Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in…
- Trial name
- NCT04040075
- Testing
- Biktarvy Tab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Southampton Healthcare, Inc.
Triple Negative Breast Cancer, Immune Checkpoint Inhibitor
LAG3 Expression in Triple Negative Breast Cancer
This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.
- Trial name
- NCT06259162
- Testing
- LAG-3 expression / immune checkpoint protein expression
- Where
- South Korea
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Pancreatic Neoplasms
Lag-3 and Gemcitabine for Treatment of Advanced Pancreas Cancer
The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine.
- Trial name
- NCT00732082
- Testing
- Gemcitabine, LAG-3
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Washington University School of Medicine
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride)…
- Trial name
- NCT01800227
- Testing
- Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
HIV, HIV Infections
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in…
- Trial name
- EYEWITNESS (NCT05911360)
- Testing
- DTG/3TC
- Where
- 56 sites in United States, Austria and 10 more
- Volunteers
- 205 people
- Sponsor
- ViiV Healthcare
Healthy
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects.
- Trial name
- NCT01540487
- Testing
- linagliptin/metformin(high dose), Linagliptin/metformin(low dose)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim