Clinical trials: FDC
Pulmonary Disease, Chronic Obstructive
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components…
- Trial name
- NCT01431274
- Testing
- tiotropium + olodaterol, tiotropium, olodaterol
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 2,624 people
- Sponsor
- Boehringer Ingelheim
HIV-1 Infection
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of…
- Trial name
- NCT02652624
- Testing
- E/C/F/TAF, E/C/F/TDF, ATV
- Where
- 56 sites in United States, Dominican Republic and 4 more
- Volunteers
- 472 people
- Sponsor
- Gilead Sciences
PD-L1-selected Solid Tumors
A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected…
- Trial name
- SKYSCRAPER-11 (NCT05661578)
- Testing
- Tiragolumab and Atezolizumab IV FDC
- Where
- 32 sites in United States, China and 7 more
- Volunteers
- 64 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV)…
- Trial name
- NCT02251717
- Testing
- LDV/SOF
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 114 people
- Sponsor
- Gilead Sciences
Chronic Obstructive Pulmonary Disease
Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)
This is a single cohort, prospective post approval study conducted on patients with COPD in Canada. The study will enroll patients that have not responded to their current treatment of tiotropium alone, or who are on the fixed…
- Trial name
- POWER (NCT02202616)
- Testing
- Glycopyrronium /Indacaterol maleate
- Where
- Canada
- Volunteers
- 401 people
- Sponsor
- Novartis Pharmaceuticals
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
Pulmonary Disease, Chronic Obstructive
Cardiovascular Function in COPD Patients
The objectives of the study are to explore the effect of treatment with tiotropium + olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC on: reversal of left ventricular diastolic…
- Trial name
- NCT03055988
- Testing
- Tiotropium, Olodaterol, Fluticasone propionate
- Where
- 10 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Boehringer Ingelheim
Healthy
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets…
- Trial name
- NCT02821910
- Testing
- High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR, High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of…
- Trial name
- NCT02616029
- Testing
- E/C/F/TAF
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 66 people
- Sponsor
- Gilead Sciences
HIV, HIV Infections
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing…
- Trial name
- NCT01815736
- Testing
- E/C/F/TAF, E/C/F/TDF, EFV/FTC/TDF
- Where
- 167 sites in United States, Australia and 18 more
- Volunteers
- 1,443 people
- Sponsor
- Gilead Sciences
Hypertension
Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension
This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC over monotherapies).
- Trial name
- NCT01977794
- Testing
- Bisoprolol/Amlodipine (Bisoprolol failed group), Bisoprolol/Amlodipine (Amlodipine failed group)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
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
Pulmonary Disease, Chronic Obstructive
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in…
- Trial name
- NCT01964352
- Testing
- tiotropium, olodaterol
- Where
- 77 sites in United States, Belgium and 8 more
- Volunteers
- 813 people
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian…
- Trial name
- NCT03501277
- Testing
- Alogliptin, Pioglitazone, SYR-322-4833 BL
- Where
- Russia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Takeda
Chronic Obstructive Pulmonary Disease
Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and potentially also asthma (in combination with an…
- Trial name
- NCT02814656
- Testing
- AZD8871
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Rhinitis, Allergic, Perennial and Seasonal
A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)
This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine…
- Trial name
- NCT01957202
- Testing
- FF/levocabastine, FF, levocabastine
- Where
- Austria
- Volunteers
- 71 people
- Sponsor
- GlaxoSmithKline
HIV-1 Infection
Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of…
- Trial name
- BRAAVE 2020 (NCT03631732)
- Testing
- B/F/TAF, NRTIs, Third Agent
- Where
- 82 sites in United States
- Volunteers
- 496 people
- Sponsor
- Gilead Sciences
Type 2 Diabetes Mellitus
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c).
- Trial name
- NCT00993187
- Testing
- Sitagliptin/Metformin FDC, Comparator: Glimepiride
- Volunteers
- 292 people
- Sponsor
- Merck Sharp & Dohme LLC