Clinical trials: FDC
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
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
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
Healthy
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).
- Trial name
- NCT01216397
- Testing
- Linagliptin/Metformin (standard batch), Linagliptin/Metformin (side batch)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food
The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination…
- Trial name
- NCT01189201
- Testing
- BI 10773/linagliptin, BI 10773/linagliptin SID, BI 10773/linagliptin FDC
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (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
- NCT02084082
- Testing
- Linagliptin/Metformin ER FDC, Linagliptin, Metformin ER
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in…
- Trial name
- NCT01344629
- Testing
- Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when…
- Trial name
- NCT01845077
- Testing
- 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC, 5 mg Linagliptin (Tradjenta)
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
Chronic Obstructive Pulmonary Disease
Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and potentially also asthma (in combination with an…
- Trial name
- NCT02814656
- Testing
- AZD8871
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca