Clinical trials: FDC
Healthy
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).
- Trial name
- NCT01216397
- Testing
- Linagliptin/Metformin (standard batch), Linagliptin/Metformin (side batch)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with…
- Trial name
- NCT02164513
- Testing
- fluticasone furoate (FF), vilanterol (VI), umeclidinium bromide (UMEC)
- Where
- 998 sites in United States, Argentina and 35 more
- Volunteers
- 10,355 people
- Sponsor
- GlaxoSmithKline
Chronic Obstructive Pulmonary Disease
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive…
- Trial name
- DETECT (NCT02552160)
- Where
- 180 sites in Germany
- Volunteers
- 3,732 people
- Sponsor
- AstraZeneca
Human Immunodeficiency Virus (HIV)
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.
- Trial name
- NCT05197075
- Testing
- DRV/COBI FDC
- Where
- 6 sites in United States, South Africa and 1 more
- Volunteers
- 15 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in…
- Trial name
- NCT01344629
- Testing
- Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypertension (HTN)
A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease
A study Comparing the Clinical Benefit of Finerenone Versus a Fixed-Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients with Hypertension and Chronic Kidney Disease.
- Trial name
- NEPHRON (NCT07223502)
- Testing
- Combination Product: FDC of spironolactone and ER torsemide, Combination Product: Stabilized doses of loop diuretic and finerenone
- Where
- United States
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Healthy
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when…
- Trial name
- NCT01845077
- Testing
- 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC, 5 mg Linagliptin (Tradjenta)
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
Bioequivalence Study for Acarbose/Metformin FDC
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and…
- Trial name
- NCT04065581
- Testing
- Acarbose/Metformin FDC(BAY81-9783), Glucobay, Glucophage
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Colitis, Ulcerative
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active…
- Trial name
- NCT03893565
- Testing
- GSK2831781 - Double Blind Phase, GSK2831781 - Open Label phase
- Where
- 61 sites in United States, Bulgaria and 13 more
- Volunteers
- 104 people
- Sponsor
- GlaxoSmithKline
Healthy
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets…
- Trial name
- NCT01508195
- Testing
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Chemotherapy-induced Nausea and Vomiting
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion…
- Trial name
- NCT03403712
- Testing
- fosnetupitant/ palonosetron, netupitant/palonosetron, dexamethasone
- Where
- 40 sites in United States, Georgia
- Volunteers
- 404 people
- Sponsor
- Helsinn Healthcare SA
Asthma
A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma
A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by…
- Trial name
- NCT02924688
- Testing
- FF/UMEC/VI (100/31.25/25) mcg, FF/UMEC/VI (100/62.5/25) mcg, FF/UMEC/VI (200/31.25/25) mcg
- Where
- 409 sites in United States, Argentina and 13 more
- Volunteers
- 2,436 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with…
- Trial name
- CITRINO (NCT03250832)
- Testing
- TSR-033, Dostarlimab, mFOLFOX6
- Where
- 12 sites in United States, France
- Volunteers
- 111 people
- Sponsor
- Tesaro, Inc.
Neoplasms by Site
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or…
- Trial name
- NCT01968109
- Testing
- Relatlimab, Nivolumab, BMS-986213
- Where
- 54 sites in United States, Australia and 13 more
- Volunteers
- 1,482 people
- Sponsor
- Bristol-Myers Squibb
Pulmonary Disease, Chronic Obstructive
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
- Trial name
- NCT01533922
- Testing
- Tiotropium, Olodaterol, tiotropium + olodaterol
- Where
- 44 sites in United States, Argentina and 8 more
- Volunteers
- 295 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus Infection
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response…
- Trial name
- NCT02123654
- Testing
- Daclatasvir, Asunaprevir, DCV 3DAA
- Where
- 35 sites in Japan
- Volunteers
- 297 people
- Sponsor
- Bristol-Myers Squibb
Malignancies
Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in…
- Trial name
- NCT03005782
- Testing
- REGN3767, cemiplimab
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy Subjects
A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
- Trial name
- NCT05236998
- Testing
- SID1903 (FDC), Dapagliflozin and Sitagliptin
- Where
- South Korea
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Dyslipidemia & Hypertension
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects…
- Trial name
- NCT01975961
- Testing
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
- Where
- South Korea
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Melanoma
Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies
The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
- Trial name
- NCT04370704
- Testing
- INCAGN02385, INCAGN02390, INCMGA00012.
- Where
- 17 sites in United States, Australia
- Volunteers
- 61 people
- Sponsor
- Incyte Corporation