Clinical trials: FDC
Diabetes Mellitus, Type 2
Bioequivalence Study for Acarbose/Metformin FDC
The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and…
- Trial name
- NCT04065581
- Testing
- Acarbose/Metformin FDC(BAY81-9783), Glucobay, Glucophage
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
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 Subjects
A Pharmacokinetic Study of SID1903 (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 SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
- Trial name
- NCT05236998
- Testing
- SID1903 (FDC), Dapagliflozin and Sitagliptin
- Where
- South Korea
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Dyslipidemia & Hypertension
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects…
- Trial name
- NCT01975961
- Testing
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
- Where
- South Korea
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy Subjects
A Pharmacokinetic Study of SID1903 (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 SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
- Trial name
- NCT05453786
- Testing
- SID1903, SID1903-R1/SID1903-R2
- Where
- South Korea
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Bioavailability Heathy Volunteers
Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone
To study intrasubject variability and steady-state pharmacokinetics of multiple-doses of Extended Release Torsemide and Spironolactone Fixed Dose Combination (FDC) tablets given together in healthy adult subjects.
- Trial name
- NCT07046975
- Testing
- Torsemide and Spironolactone tablet, Torsemide Tablets and Spironolactone Tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Prostatic Hyperplasia
Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States
This study will be an open-label, randomized, single dose, three way crossover study in healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of two formulations of a fixed dose combination…
- Trial name
- NCT02184585
- Testing
- Treatment sequence A, Treatment sequence B, Treatment sequence C
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50…
- Trial name
- NCT00929201
- Testing
- Sitagliptin phosphate/metformin hydrochloride FDC, Sitagliptin phosphate, Metformin hydrochloride
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
T2DM
Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
- Trial name
- NCT04544319
- Testing
- Zemiglo 50mg and Forxiga 10mg, Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- LG Chem
Type 2 Diabetes
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of…
- Trial name
- NCT00961480
- Testing
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500mg, Comparator: sitagliptin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine High Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Trial name
- NCT05688098
- Testing
- Irbesartan/Amlodipine High FDC, Irbesartan, Amlodipine High
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Biological Availability, Healthy Participants
A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants
Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent.
- Trial name
- NCT06397144
- Testing
- Paxlovid, Nirmatrelvir/ritonavir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
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 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
- NCT06124573
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Triple Negative Breast Cancer, Immune Checkpoint Inhibitor
LAG3 Expression in Triple Negative Breast Cancer
This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.
- Trial name
- NCT06259162
- Testing
- LAG-3 expression / immune checkpoint protein expression
- Where
- South Korea
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Healthy
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) 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
- NCT02084056
- Testing
- Linagliptin, Metformin, Linagliptin/Metformin FDC
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- 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
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
- Trial name
- NCT02129192
- Testing
- Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen Lysinate
To investigate the relative bioavailability of ibuprofen from a (FDC) film-coated tablet of ibuprofen and caffeine vs. a tablet of ibuprofen (Brufen®) and a tablet of ibuprofen lysinate (Nurofen Immedia®).
- Trial name
- NCT01879371
- Testing
- Ibuprofen+caffeine FDC, Ibuprofen (Nurofen Immedia®), Ibuprofen (Brufen®)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypertension, Essential
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it…
- Trial name
- NCT01227603
- Testing
- Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040), Candesartan (Atacand)
- Where
- Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bayer