Clinical trials: Therapeutic Equivalency, Healthy
Healthy Volunteer
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.
- Trial name
- RTV (NCT03302182)
- Testing
- Ritonavir for cycle1 and NORVIR for cycle 2, NORVIR for cycle 1 and Ritonavir for cycle 2
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Healthy
Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
- Trial name
- NCT01132196
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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
Healthy Male and Female Subjects
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by…
- Trial name
- NCT07036861
- Testing
- Ibuprofen 2%, Ibuprofen 4%
- Where
- 2 sites in Lithuania
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy Volunteer
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting condition.
- Trial name
- NCT03214159
- Testing
- Ritonavir Tablet 100mg, NORVIR tablet 100mg
- Where
- 2 sites in China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to…
- Trial name
- NCT00897390
- Testing
- Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Glimepiride 1mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 1 mg tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets following a single oral dose (1 x 1 mg tablet) in…
- Trial name
- NCT00776490
- Testing
- Glimepiride 1mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fed conditions.
- Trial name
- NCT00841659
- Testing
- Paroxetine HCl, Paxil®
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Diabetes Mellitus, Type 2
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus.
- Trial name
- NCT02660736
- Testing
- Albiglutide Liquid Auto-injector, Albiglutide Lyophilized DCC Pen Injector
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
- Trial name
- NCT06244407
- Testing
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Epilepsy
Bioequivalence and Food Effect of 250mg of Lamotrigine XR
This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers
- Trial name
- NCT00605371
- Testing
- Lamotrigine tablet, Lamotrigine caplet
- Where
- United States
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Famciclovir 500 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions.
- Trial name
- NCT00834444
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy adult…
- Trial name
- NCT00648700
- Testing
- Levothyroxine Sodium Tablets 300 μg, Levothroid® Tablets 300 μg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI]…
- Trial name
- NCT02823171
- Testing
- Treatment A: 400 mg Pacritinib P3CT, Treatment B: 400 mg of pacritinib FMI
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Healthy Volunteers
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
- Trial name
- NCT04421885
- Testing
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Acquired Bleeding Disorder, Acquired Haemophilia
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency
- Trial name
- NCT01561417
- Testing
- activated recombinant human factor VII
- Where
- France
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Hypercholesterolemia
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917579
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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