Clinical trials: Therapeutic Equivalency
Healthy
A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions
The purpose of this study is compare the relative bioavailability of 750 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company…
- Trial name
- NCT00865852
- Testing
- Metformin HCl 750 mg Extender Release tablets, single dose, GLUCOPHAGE® XR 750 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy, Dermal Pharmacokinetic Measurements
An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)
The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products.
- Trial name
- NCT04050826
- Testing
- Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA), Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)
- Where
- Austria
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Joanneum Research Forschungsgesellschaft mbH
Atopic Dermatitis
Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single…
- Trial name
- NCT05945810
- Testing
- TLL-018 extended-release tablet, TLL-018 immediate-release tablet
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
Healthy
Bioequivalence Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fed Conditions
The objective of this study was to compare the single-dose oral bioavailability of metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of Bristol-Myers, USA following administration of a…
- Trial name
- NCT00780013
- Testing
- metformin hydrochloride liquid 500 mg per 5 mL
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
- Trial name
- NCT00877955
- Testing
- alprazolam sublingual tablet commercial, alprazolam sublingual tablet test
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin.
- Trial name
- NCT03334448
- Testing
- LY900014-U200, LY900014-U100
- Where
- Singapore
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes, Healthy
Comparison of Two NN1250 Formulations in Healthy Volunteers
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.
- Trial name
- NCT00966368
- Testing
- insulin degludec
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA…
- Trial name
- NCT00835497
- Testing
- 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets, 5 mg/500 mg METAGLIP™ Tablets
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of…
- Trial name
- NCT01154218
- Testing
- crizotinib
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Sertraline Hydrochloride 100 mg Tablets, Fasting
The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fasting conditions.
- Trial name
- NCT00836849
- Testing
- Zoloft® 100 mg Tablets, Sertraline hydrochloride 100 mg Tablets
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.
- Trial name
- NCT03251248
- Testing
- MSB11455, Neulasta
- Where
- 2 sites in Australia
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Healthy
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.
- Trial name
- NCT01421043
- Testing
- triazolam liquid oral drops, triazolam tablets
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr.
- Trial name
- NCT01064115
- Testing
- Cetirizine Hydrochloride
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence Evaluation of a New and Current Tablet of ASP015K
The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
- Trial name
- NCT02531191
- Testing
- peficitinib
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hypertension
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
- Trial name
- NCT01389609
- Testing
- Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water, Doxazosin 4 mg ODT without water
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558045
- Testing
- Rivaroxaban 20 mg film-coated tablet, Xarelto 20 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Hypertension
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.
- Trial name
- NCT00883506
- Testing
- Lisinopril 40 mg Tablet (Zestril) under fed conditions., Lisinopril 40 mg Tablet under fasting conditions., Lisinopril 40 mg Tablet under fed conditions.
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT02322658
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
- Trial name
- NCT00648440
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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