Clinical trials: FDC
Hepatitis C
Drug Interaction & Methadone & Buprenorphine
The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on…
- Trial name
- NCT02045693
- Testing
- Methadone, DCV 3DAA FDC, BMS-791325
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers
The goal of this clinical trial is to evaluate the safety and tolerability of single and multiple doses of IMP761 in healthy female and male volunteers aged 18-55 with no history of disease affecting the immune system or recent…
- Trial name
- NCT06637865
- Testing
- IMP761, keyhole limpet haemocyanin (KLH)
- Where
- Netherlands
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Immutep S.A.S.
Healthy
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and…
- Trial name
- NCT01463228
- Testing
- A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets), B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Asthma
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY)…
- Trial name
- ADITION (NCT04656223)
- Testing
- MF/IND/GLY plus sensor system, FDC therapy
- Where
- 26 sites in Germany
- Volunteers
- 434 people
- Sponsor
- Novartis Pharmaceuticals
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
Essential Hypertension
A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
The purpose of this study is to evaluate the safety by assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters including laboratory values…
- Trial name
- NCT04470830
- Where
- South Korea
- Volunteers
- 718 people
- Sponsor
- Celltrion Pharm, Inc.
HIV-1
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets…
- Trial name
- NCT02993237
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Janssen Research & Development, LLC
Advanced Solid Tumor
Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor…
- Trial name
- NCT05101109
- Testing
- ABL501
- Where
- 4 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- ABL Bio, Inc.
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
Gout
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in…
- Trial name
- NCT03272425
- Testing
- lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
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
Healthy Volunteers
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs
The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 20mg and Metformin XR 1000mg with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT03787017
- Testing
- FDC(MP-513 20mg/Metformin XR 1000mg), MP-513 20mg, Metformin XR 1000mg
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Healthy
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) 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 canagliflozin and metformin…
- Trial name
- NCT01454622
- Testing
- A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets), B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Metastatic Cancer, Solid Tumor
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by…
- Trial name
- NCT04641871
- Testing
- Sym021, Sym022, Sym023
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 78 people
- Sponsor
- Symphogen A/S
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
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
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