Clinical trials: FDC
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
Hypertension, Essential
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed…
- Trial name
- NCT01350609
- Testing
- Nifedipine/Candesartan (BAY 98-7106), Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
- Where
- Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bayer
Hypertension
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
- Trial name
- NCT00556920
- Testing
- COREG CR
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects.
- Trial name
- NCT01540487
- Testing
- linagliptin/metformin(high dose), Linagliptin/metformin(low dose)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Arrhythmogenic Right Ventricular Cardiomyopathy, Cardiomyopathies
Mayo AVC Registry and Biobank
Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous.
- Conditions
- Arrhythmogenic Right Ventricular Cardiomyopathy, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT03049254
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Healthy
Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability
This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.
- Trial name
- NCT02581553
- Testing
- lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
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.
Healthy Subjects
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fast condition.
- Trial name
- NCT05874167
- Testing
- DW6013
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
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
Healthy
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when…
- Trial name
- NCT01975220
- Testing
- Empagliflozin/Metformin XR, FDC, Empagliflozin/Metformin XR FDC, 25 mg Empagliflozin/1000 mg Metformin XR, FDC
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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.
Hepatitis C
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess…
- Trial name
- NCT02045966
- Testing
- Cocktail, DCV 3DAA FDC, BMS-791325
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 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
- NCT01518712
- 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.
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
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.
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 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
- NCT06124495
- Testing
- Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy Subjects
BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed 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
- NCT02962258
- Testing
- Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets, Tribenzor of Daichi Sankyo Inc. USA
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
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
Healthy Volunteers
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian…
- Trial name
- NCT03501277
- Testing
- Alogliptin, Pioglitazone, SYR-322-4833 BL
- Where
- Russia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Takeda