Clinical trials: Therapeutic Equivalency
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
Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects
In recent years, novel oral anticoagulants (NOACs) such as Factor Xa inhibitors and direct thrombin inhibitors (e.g., dabigatran etexilate) have emerged.
- Trial name
- NCT06876623
- Testing
- dabigatran etexilate mesylate capsules 150mg
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital Of Guizhou Medical University
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.
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Pomalidomide Bioequivalence Study in Healthy Volunteers
Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects
This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane® 4 mg hard capsule) compared with the reference formulation (Imnovid® 4 mg hard capsule) in healthy male subjects under fasting…
- Trial name
- PRO-BEQ-PMD-00 (NCT07694011)
- Testing
- Xetrane® (Pomalidomide) 4 mg Hard Capsule, Imnovid® (Pomalidomide) 4 mg Hard Capsule
- Where
- Chile
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Knight Therapeutics (USA) Inc
Healthy
Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride in Healthy Male Subjects
The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4 mg capsules in healthy male subjects.
- Trial name
- NCT02266511
- Testing
- Flomax®, Norman II facility, Flomax®, Nishine facility
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Acute Coronary Syndrome
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
- Trial name
- NCT01358344
- Testing
- Pantoprazole, SCH 530348 (high percentage), SCH 530348 (standard percentage)
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting 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 fasted conditions.
- Trial name
- NCT01222975
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
- Trial name
- NCT07789028
- Testing
- Zongertinib, Formulation A, reference product, Zongertinib Formulation B, test product
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.
- Trial name
- NCT01020136
- Testing
- AG-013736
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pain
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.
- Trial name
- NCT01769677
- Testing
- 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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