Clinical trials: Therapeutic Equivalency
Therapeutic Equivalency
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or…
- Trial name
- NCT01436526
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bayer
Advanced Solid Tumors, Excluding Breast Cancer
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer.
- Trial name
- NCT01421004
- Testing
- TKI258
- Where
- 14 sites in United States
- Volunteers
- 166 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for…
- Trial name
- NCT00648271
- Testing
- Metoprolol Tartrate Tablets 25 mg, Lopressor® Tablets 50 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.
- Trial name
- NCT05581693
- Testing
- L04RD1, L04TD2
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
Bioequivalence, Healthy Japanese Subjects
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.
- Conditions
- Bioequivalence, Healthy Japanese Subjects, Pharmacokinetics
- Trial name
- NCT02436577
- Testing
- Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy…
- Trial name
- NCT00648557
- Testing
- Levothyroxine Sodium Tablets 200 mg, Synthroid Tablets 200 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products
The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin.
- Trial name
- NCT01592019
- Testing
- Reference, Patch location thigh, batch 1, Test, Patch location thigh, batch 2, Reference, Patch location abdomen, batch 1
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Florida
Epilepsy
Characterization of Epilepsy Patients BEEP 2b
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products.
- Trial name
- BEEP2b (NCT02707965)
- Testing
- Oxcarbazepine (brand name vs generic drugs), Divalproex Sodium (brand name vs generic drugs), Carbamazepine (brand name vs generic drugs)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Food and Drug Administration (FDA)
Healthy
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
- Trial name
- NCT00864565
- Testing
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Infections, Bacterial
A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions
Cefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis.
- Trial name
- NCT03329547
- Testing
- Cefixime test capsule, Cefixime reference capsule
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fasting
A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer…
- Trial name
- NCT01602055
- Testing
- Azithromycin
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT Novell Pharmaceutical Laboratories
Growth Failure, Growth Hormone Deficiency
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg…
- Trial name
- NCT01034735
- Testing
- r-hGH liquid (Saizen), r-hGH freeze-dried
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- EMD Serono
Bronchial Asthma
Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of…
- Trial name
- QVR (NCT04051710)
- Testing
- Test Product, Reference Product
- Where
- India
- Volunteers
- 1,550 people
- Sponsor
- Aurobindo Pharma Ltd
Urologic Diseases
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligram…
- Trial name
- NCT02052713
- Testing
- Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg, Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects
The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO Retard (isosorbide -5 -mononitrate extended…
- Trial name
- NCT03557580
- Testing
- IS-5-MN R, IS-5-MN T1, IS-5-MN T2
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Intestinal Diseases
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.
- Trial name
- NCT06201559
- Testing
- Albendazole IP 400 mg, Albendazole 400 mg
- Where
- India
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Advanced Solid Tumors, Solid Tumors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft…
- Conditions
- Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04672460
- Testing
- TALZENNA capsule, Talazoparib soft gel capsule
- Where
- 31 sites in United States, Australia
- Volunteers
- 73 people
- Sponsor
- Pfizer
Healthy
Food Study Metformin Hydrochloride ER Tablets 750 mg and Glucophage XR 750 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under…
- Trial name
- NCT00649350
- Testing
- Metformin Hydrochloride ER Tablets 750 mg, Glucophage XR 750 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Seasonal Allergic Rhinitis
A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis
This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of…
- Trial name
- NCT02273817
- Testing
- Ciclesonide nasal spray, 50 μg per actuation.
- Volunteers
- 580 people
- Sponsor
- Apotex Inc.
Nasal Congestion
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
- Trial name
- NCT01354418
- Testing
- Phenylephrine HCl Extended Release, Phenylephrine HCl Immediate Release
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
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