Clinical trials: Therapeutic Equivalency
Diabetes Mellitus
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal
This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal.
- Trial name
- NCT02634528
- Testing
- Julphar Insulin N (human isophane insulin), Huminsulin® Basal (NPH, human isophane insulin)
- Where
- Germany
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Julphar Gulf Pharmaceutical Industries
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Bioequivalence Study
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult…
- Trial name
- NCT06579053
- Testing
- Spironolactone Tablets (Test), Spironolactone Tablets (Reference)
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd.
Hematological Malignancy
A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)
The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.
- Trial name
- NCT06586671
- Testing
- Nemtabrutinib
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prostatic Hyperplasia
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Two tamsulosin HClformulations will be tested in fed state
- Trial name
- NCT02417844
- Testing
- tamsulosin (Astellas), Tamsulosin HCL
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Major Depressive Disorder (MDD)
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)]…
- Trial name
- NCT05417087
- Testing
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets, Vortioxetine Hydrobromide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01511705
- Testing
- Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States
China Food and Drug Administration (CFDA) initiated a generic consistency evaluation program to evaluate the quality and efficacy of the products manufactured in China in 2016.
- Trial name
- NCT03353480
- Testing
- Azithromycin Tablet manufactured in China, Azithromycin Tablet manufactured in US
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Healthy
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.
- Trial name
- NCT00881894
- Testing
- Rotigotine transdermal patch
- Where
- Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
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
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions
The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth under fed conditions.
- Trial name
- NCT07470866
- Testing
- Tafamidis (Reference), Tafamidis (Test)
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Obese
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese…
- Conditions
- Healthy, Obese, Overweight, Obesity
- Trial name
- NCT06440980
- Testing
- Orforglipron
- Where
- 7 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Solid Tumor
A Bioequivalence Study to Compare Senaparib Manufactured at 2 Sites in Healthy Subjects in Fasting State
An Open-label, Randomized, Single-dose, Two-way Crossover Study to Compare the Bioequivalence of Senaparib 10 mg Capsules Manufactured at Different Manufacturing Sites After Administration in Fasting State in Healthy Chinese…
- Trial name
- NCT07030439
- Testing
- Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd., Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr.
- Trial name
- NCT01513044
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fasting State
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study.
- Trial name
- NCT01603134
- Testing
- Allopurinol
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Seasonal Allergic Rhinitis
A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)
The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.
- Trial name
- NCT01673659
- Testing
- Mometasone furoate, Nasonex Nasal Spray
- Where
- United States
- Volunteers
- 1,220 people
- Sponsor
- Padagis LLC
Healthy
Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study on fenofibrate formulations comparing fenofibrate 160 mg tablets of Ranbaxy…
- Trial name
- NCT00775827
- Testing
- fenofibrate 160 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product
This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The Pilot study will be performed at a single site with 30 subjects.
- Trial name
- NCT04194905
- Testing
- Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product, Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product
- Where
- Chile
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
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