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
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.
Type 2 Diabetes
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
- Trial name
- NCT01747083
- Testing
- FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers
Phase 1 Bioavailability Study of SYR-322MET
The purpose of this study is to determine the relative bioavailability of alogliptin 12.5 milligram (mg) and immediate-release metformin 1000 mg when administered as individual tablets and as a fixed-dose combination (FDC)…
- Trial name
- NCT02508168
- Testing
- Alogliptin, Metformin Hydrochloride, SYR-322MET
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Hypertension
Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
This will be an open-label, single-dose, non-randomized, five-period crossover study in healthy volunteers. The duration of the study will last up to eleven weeks from screening to follow-up. PK samples will be taken.
- Trial name
- NCT00549510
- Testing
- COREG CR and lisinopril (FDC)
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Healthy
Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence
This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects
- Trial name
- NCT02888054
- Testing
- lesinurad/allopurinol 200/300 FDC tablet, lesinurad 200 mg, allopurinol 300 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
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 Volunteer
Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects
This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β…
- Trial name
- NCT05118516
- Testing
- ASC43F
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Gannex Pharma Co., Ltd.
Phase 1, Bioavailability
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three…
- Conditions
- Phase 1, Bioavailability, Healthy Subjects
- Trial name
- NCT02010944
- Testing
- solifenacin succinate, mirabegron, mirabegron/solifenacin succinate
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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.
Healthy
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and…
- Trial name
- NCT02121509
- Testing
- Linagliptin, Linagliptin/Metformin ER FDC, Metformin ER
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of…
- Trial name
- NCT00961857
- Testing
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg, Comparator: sitagliptin
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed 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
- NCT06124547
- Testing
- Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Bioavailability Heathy Volunteers
A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects
This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.
- Trial name
- NCT07043634
- Testing
- FDC (24 mg ER torsemide and 30 mg Spironolactone) without food, FDC (24 mg ER torsemide and 30 mg Spironolactone) with food
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Type 2 Diabetes
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and…
- Trial name
- NCT01093794
- Testing
- Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet, Co-administration of 50 mg sitagliptin and 850 mg metformin
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of…
- Trial name
- NCT05027126
- Testing
- Dexketoprofen 25 MG, Fixed dose Dexketoprofen-Vitamin B Complex
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
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
Prostatic Hyperplasia
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg…
- Trial name
- NCT02509104
- Testing
- FDC capsule of dutasteride and tamsulosin, Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline