Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
Diabetes, Healthy
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.
- Trial name
- NCT01490099
- Testing
- insulin detemir
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Novo Nordisk A/S
Therapeutic Equivalency
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
- Trial name
- NCT01405157
- Testing
- methylprednisolone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.
- Trial name
- NCT00803465
- Testing
- Fluticasone Propionate 0.05% Cream-Reference Product, Fluticasone Propionate 0.05% Cream-Test product
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
Mycophenolate Mofetil Tablets Under Fed Conditions
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg Tablets (reference), after a single-dose in healthy subjects under fed…
- Trial name
- NCT00908128
- Testing
- Mycophenolate Mofetil, CellCept®
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pharmacokinetics, Safety
Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.
- Trial name
- NCT05381870
- Testing
- Test Preparation-Reference preparation, Reference preparation-Test Preparation
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Osteoporosis
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence…
- Trial name
- NCT06753864
- Testing
- Test (T), Reference (R)
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Fasting Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting…
- Trial name
- NCT00649571
- Testing
- Doxycycline Monohydrate Tablets (100 mg, Adoxa Tablets 100 mg
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Subject
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets
This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.
- Trial name
- NCT06154434
- Testing
- Chlorpromazine HCl 100mg Tablets
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Whanin Pharmaceutical Company
Healthy
A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Fasting Conditions
To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fasted conditions.
- Trial name
- NCT00864279
- Testing
- Cetirizine Hydrochloride 10 mg tablets, single dose, Zyrtec® 10 mg tablets, single dose
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.
- Trial name
- NCT00847405
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
To compare the single-dose Bioavailability of Kali and Aventis
- Trial name
- NCT00653003
- Testing
- Leflunomide, ARAVA
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting…
- Trial name
- NCT07610005
- Testing
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Healthy Subjects
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects
The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed…
- Trial name
- NCT03215966
- Testing
- Macitentan / tadalafil FDC, Macitentan (Opsumit®), Tadalafil (Adcirca®)
- Where
- Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in…
- Trial name
- NCT00864305
- Testing
- Gabapentin 400 mg capsules, NEURONTIN® 400 mg capsules, Gabapentin 400 mg capsules, single dose
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fast Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-IC004 (NCT07763951)
- Testing
- Janumet XR, Sitagliptin/Metformin FDC
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
Fasting State
Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition
This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference…
- Trial name
- NCT01603173
- Testing
- Quetiapine Fumarate Tablets 25 mg, Quetiapine Fumarate
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Type 2 Diabetes
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
Objective: To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers…
- Trial name
- NCT01089205
- Testing
- Metformin
- Sponsor
- Torrent Pharmaceuticals Limited
Bronchial Asthma
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
- Trial name
- NCT02624505
- Testing
- 90 mcg Reference Product, 180 mcg Reference Product, 90 mcg Test Product
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Cipla Ltd.
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