Clinical trials: Therapeutic Equivalency
Malaria
Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet
The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose…
- Trial name
- NCT00682630
- Testing
- pyronaridine artesunate clinical trial reference tablets, pyronaridine artesunate to-be-marketed tablets
- Where
- Switzerland
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy Adult Participants
A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.
- Trial name
- NCT03437564
- Testing
- Vortioxetine
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Takeda
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the…
- Trial name
- NCT02246920
- Testing
- Fluticasone propionate, Flonase®
- Where
- United States
- Volunteers
- 1,474 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Levetiracetam 750 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet under fasting conditions.
- Trial name
- NCT00849862
- Testing
- Levetiracetam, Keppra®
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
- Trial name
- NCT01101178
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Infections, Bacterial
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
- Trial name
- NCT03150082
- Testing
- GR37547 tablet, Ciprofloxacin reference tablet
- Where
- South Africa
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Trandolapril 4 mg Tablet Under Non-Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00840073
- Testing
- Trandolapril 4 mg Tablets, Mavik® 4 mg Tablets
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
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
Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT00829309
- Testing
- Pravastatin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.
- Trial name
- NCT06393127
- Testing
- Nerandomilast
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by…
- Trial name
- NCT00829426
- Testing
- Alprazolam Extended-Release 3 mg Tablets
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Solid Tumor
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
- Trial name
- NCT04035473
- Testing
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
- Where
- 7 sites in Australia, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Athenex, Inc.
Type 2 Diabetes Mellitus
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
- Trial name
- NCT01068730
- Testing
- metformin (Diabex), metformin (Glucophage™)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference)…
- Trial name
- NCT05644353
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.
- Trial name
- NCT01151345
- Testing
- TILACEM, ANGIOTROFIN
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices.
- Trial name
- NCT05810597
- Testing
- Tirzepatide, Single Dose Pen, Multi-use Prefilled Pen
- Where
- 3 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Adult Subjects
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
- Trial name
- NCT04493281
- Testing
- MT-1186, MCI-186
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shionogi