Clinical trials: Therapeutic Equivalency
Asthma
Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
When a drug company first develops a drug, the company has to show the Food and Drug Administration (FDA) that the drug is safe and effective. If FDA concludes that the drug is safe and effective, FDA approves the drug.
- Trial name
- NCT01966692
- Testing
- Fluticasone Propionate Formulation 1, Fluticasone Propionate Formulation 2, Fluticasone Propionate Formulation 3
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Florida
Pain
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
- Trial name
- NCT01316978
- Testing
- Ibuprofen
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy Volunteers
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition
The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil…
- Trial name
- NCT01080443
- Testing
- Mycophenolate Mofetil Capsule 250 mg
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Bioequivalence
A Pivotal Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04466176
- Testing
- Test Product, Reference Product
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Zaleplon 10 mg Capsules Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in…
- Trial name
- NCT00829868
- Testing
- Zaleplon 10 mg Capsules, SONATA® 10 mg capsules
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pharmacokinetics, Bioequivalence
Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method
Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France)…
- Trial name
- NCT04501250
- Testing
- Rinsulin NPH, Humulin NPH
- Where
- Russia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Geropharm
Pain
Bioequivalence Study for Mejoral 500 Product
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
- Trial name
- NCT02504775
- Testing
- Mejoral® 500 Tablets, Tylenol® Caplets
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled…
- Trial name
- NCT02806219
- Testing
- Prefilled syringe (PFS), e-Device
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES, Inc.
Healthy Volunteer
The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions
- Trial name
- NCT06244407
- Testing
- Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02311530
- Testing
- Felodipine, Felodipine (Plendil®)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
HIV INFECTIONS
Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers
The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg…
- Trial name
- NCT02604004
- Testing
- Epivir ® tablet 150-mg single dose (drug reference), Lamivudine 150-mg tablet single dose (drug test)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Universidade Federal de Pernambuco
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT06025214
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Diabetes Mellitus
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III
This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III.
- Trial name
- NCT02631928
- Testing
- human biphasic insulin, human biphasic insulin, reference
- Where
- Germany
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Julphar Gulf Pharmaceutical Industries
Neoplasms
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the…
- Trial name
- NCT03329001
- Testing
- Niraparib Tablet, Niraparib Capsule
- Where
- 16 sites in United States
- Volunteers
- 236 people
- Sponsor
- Tesaro, Inc.
Healthy
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim…
- Trial name
- NCT01936012
- Testing
- Lisinopril 10 mg tablets of PT Dexa Medica, Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Pharmacokinetics
Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers
This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US…
- Trial name
- NCT03522012
- Testing
- Tocilizumab
- Where
- Australia
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Mycenax Biotech Inc.
Diabetes Mellitus, Type 2
Avandamet Bioequivalence Study Brazil - Fed Administration
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.
- Trial name
- NCT01332071
- Testing
- Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg, Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
- Trial name
- NCT00835263
- Testing
- Lamotrigine, Lamictal®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20…
- Trial name
- NCT00649038
- Testing
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Lotensin HCT® Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Type2 Diabetes Mellitus
Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets of Humanis, Turkey and Jardiance (Empagliflozin)…
- Trial name
- NCT06180109
- Testing
- Empagliflozin film coated tablets, Jardiance film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.