Clinical trials: FDC
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
Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)
The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC) compared with the single agents when…
- Trial name
- NCT03059303
- Testing
- Simeprevir 75 mg, Odalasvir 25 mg, Odalasvir 12.5 mg
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hypertension
Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions
This is a three-period, three sequence, reference replicated, cross-over study to determine the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and…
- Trial name
- NCT01797926
- Testing
- Reference Treatment: 5 mg amlodipine + 50 mg losartan, Reference Treatment:5 mg amlodipine + 100 mg losartan, FDC 5/50 amlodipine/ losartan
- Where
- South Africa
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study of Canagliflozin and Metformin Immediate Release (150 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
- NCT01508182
- 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
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
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
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 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.
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
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
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
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.
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
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.
Healthy Volunteers
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Trial name
- NCT05663073
- Testing
- Irbesartan/Amlodipine FDC, Irbesartan, Amlodipine
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)
The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg versus co-administration of the separate…
- Trial name
- NCT02741557
- Testing
- DTG, RPV, DTG/RPV FDC
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
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.
Healthy Subjects
A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers in Fed Condition
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 fed condition.
- Trial name
- NCT05874180
- Testing
- DW6013
- Where
- South Korea
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.