Clinical trials: FDC
Hepatitis C
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy…
- Trial name
- NCT02095860
- Testing
- DCV 3DAA FDC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Pulmonary Disease, Chronic Obstructive
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in…
- Trial name
- NCT02296138
- Testing
- olodaterol, tiotropium
- Where
- 818 sites in United States, Argentina and 49 more
- Volunteers
- 7,903 people
- Sponsor
- Boehringer Ingelheim
Hepatocellular Carcinoma
Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma
Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).
- Trial name
- CLeAR (NCT07365839)
- Testing
- Arm 1 cemiplimab, Arm 2 cemiplimab and fianlimab
- Sponsor
- Virginia Commonwealth University
Healthy Volunteer, Pharmacokinetics
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60…
- Conditions
- Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI)
- Trial name
- NCT06733675
- Testing
- Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) 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 \& metformin XR and the single tablets of empagliflozin and metformin XR…
- Trial name
- NCT02106923
- Testing
- 1 tablet Empagliflozin/2 tablets Metformin XR, 10 mg Empagliflozin/1000 mg Metformin XR, 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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 Fasting 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
- NCT06124560
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy
Comparative Bioavailability Study Between Etoricoxib and Tramadol, Administered Individually or in Combination
Study carried out in the Clinical and Analytical Unit of the Department of Pharmacology and Toxicology of the Faculty of Medicine of the Autonomous University of Nuevo León, with the objective of comparing the bioavailability…
- Trial name
- NCT05533073
- Testing
- A1: Etoricoxib / Tramadol Fixed dose combination, A2: Etoricoxib, A3: Tramadol
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
HIV, Acute HIV Infection
Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).
- Trial name
- PHI-05 (NCT02384395)
- Testing
- Dolutegravir 50 mg, Lamivudine 300 mg, Abacavir 600 mg
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV-1 Infection
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen…
- Trial name
- NCT02605954
- Testing
- E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
- Where
- 49 sites in United States, France and 4 more
- Volunteers
- 275 people
- Sponsor
- Gilead Sciences
Pulmonary Disease, Chronic Obstructive
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
- Trial name
- NCT02850978
- Testing
- Spiolto
- Where
- Japan
- Volunteers
- 1,335 people
- Sponsor
- Boehringer Ingelheim
Head and Neck Squamous Cell Carcinoma (HNSCC)
Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer
The aim of this study is to potentiate adaptive immunity to enhance the anti-tumor activity of anti-PD1 antibody by the addition of anti-CTLA4 antibody or anti-LAG3 antibody (relatlimab) given in subjects with resectable locally…
- Trial name
- NCT04080804
- Testing
- Nivolumab, Relatlimab, Ipilimumab
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Dan Zandberg
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
Healthy
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups.
- Trial name
- NCT02121535
- Testing
- T80/A5 mg FDC tablet, H12.5 mg tablet, T80/A5/H12.5 ng FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Malignant Tumors(Stage IA-IB)
A Study of AK129 in Patients With Advanced Malignant Tumors
A Phase Ia/Ib, open label, dose escalation and dose extension trial of Anti-PD-1 and LAG-3 bispecific antibody, AK129, to evaluate the safety, tolerability and antitumor efficacy in patients with advanced malignant tumors
- Trial name
- NCT05645276
- Testing
- AK129 IV infusion
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Akeso
Bioequivalence Study in Healthy Subjects, PK/PD
Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone).
- Trial name
- NCT07015671
- Testing
- 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD
- Trial name
- NCT02603393
- Testing
- QVA149, Tiotropium, Salmeterol/fluticasone
- Where
- 167 sites in Argentina, Austria and 19 more
- Volunteers
- 1,053 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer.
- Trial name
- MBC1 (NCT02506777)
- Testing
- metformin, Fluoruracil, Doxorubicin
- Where
- Russia
- Volunteers
- 96 people
- Sponsor
- N.N. Petrov National Medical Research Center of Oncology
Healthy
Empa/Lina FDC Food Effect Study (Japan)
The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.
- Trial name
- NCT02815644
- Testing
- empagliflozin/linagliptin FDC
- Where
- Japan
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV/AIDS, ESRD
Pharmacokinetics of JULUCA in Hemodialysis
This study will compare the pharmacokinetics of the component drugs in JULUCA, and HIV combination treatment pill, in HIV-negative patients who require hemodialysis with those with normal renal function.
- Trial name
- NCT04431518
- Testing
- JULUCA 50Mg-25Mg Tablet
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Indiana University
Diabetes Mellitus, Type II
Bioequivalence Study for Acarbose / Metformin FDC
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- Trial name
- NCT01728740
- Testing
- Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421), Metformin
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer