Clinical trials: FDC
Hypertension
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
This study will be a randomized study investigating the bioequivalence of COREG CR to its components, COREG and Lisinopril (ZESTRIL).
- Trial name
- NCT00552708
- Testing
- COREG CR, Lisinopril
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed 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
- NCT01800240
- Testing
- Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Endometrial Cancer
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.
This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy.
- Trial name
- POD1UM-204 (NCT04463771)
- Testing
- retifanlimab, epacadostat, pemigatinib
- Where
- 65 sites in United States, Belgium and 5 more
- Volunteers
- 206 people
- Sponsor
- Incyte Corporation
Asthma, COPD
Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs
This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations (250 µg FP and 50 µg SAL) from the Advair®…
- Trial name
- NCT02215122
- Testing
- MGR001, Advair® Diskus®, Seretide™ Accuhaler™
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharma UK Ltd.
Hypertension
Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice
The primary objective of this study is to compare the medication adherence measured by PDC of patients with FDC or double-pill combination therapy in real-world Japanese therapeutic practice.The further objective of this study is…
- Trial name
- NCT03205137
- Testing
- subjects treated with telmisartan/hydrochlorothiazide, Subjects treated with Telmisartan and amlodipine, subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
- Where
- Japan
- Sponsor
- Boehringer Ingelheim
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood.
- Trial name
- NCT07619131
- Testing
- Laroprovstat, Rosuvastatin 1, Rosuvastatin 2
- Where
- 152 sites in United States, Bulgaria and 9 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
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
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
Healthy Subjects
A Pharmacokinetic Study of DW6012 (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 DW6012 and each component in healthy adult volunteers.
- Trial name
- NCT05403281
- Testing
- DW6012
- Where
- South Korea
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
Advanced Non-Small Cell Lung Cancer
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs".
- Trial name
- NCT05785767
- Testing
- fianlimab, cemiplimab
- Where
- 106 sites in United States, Australia and 9 more
- Volunteers
- 149 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy Subjects
Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA.
- Trial name
- NCT02962336
- Testing
- Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets, Tribenzor Tablets of Daichi Sankyo Inc, USA
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Type 2 Diabetes Mellitus (T2DM)
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x…
- Trial name
- NCT01002807
- Testing
- Dapagliflozin, Metformin XR, Glucophage
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Classic Hodgkin Lymphoma
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy.
- Trial name
- NCT06642792
- Testing
- AK129, AK117
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Akeso
Melanoma, Cervical Carcinoma
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess…
- Conditions
- Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer
- Trial name
- DUET-4 (NCT03849469)
- Testing
- XmAb®22841, Pembrolizumab (Keytruda®)
- Where
- 28 sites in United States
- Volunteers
- 78 people
- Sponsor
- Xencor, Inc.
Symptomatic Genetic Dilated Cardiomyopathy (DCM)
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used…
- Trial name
- KINSHIP-OLE (NCT07771465)
- Testing
- Danicamtiv
- Where
- 78 sites in United States, Belgium and 9 more
- Volunteers
- 332 people
- Sponsor
- Kardigan, Inc.
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
Breast Carcinoma
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
- Trial name
- AIPAC-003 (NCT05747794)
- Testing
- eftilagimod alpha, Paclitaxel
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 72 people
- Sponsor
- Immutep S.A.S.
Hypertension
PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton
This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.
- Trial name
- NCT02496910
- Testing
- YH22162, Telmisartan/Amlodipine 80/5 mg (FDC), Chlorthalidone 25mg
- Where
- South Korea
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy Volunteers
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Trial name
- NCT05688085
- Testing
- Irbesartan High/Amlodipine FDC, Irbesartan High, Amlodipine
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Handok Inc.