Clinical trials: Therapeutic Equivalency
Healthy
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with…
- Trial name
- NCT00830336
- Testing
- Azithromycin, Zithromax®
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Healthy
Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following a single, oral 20 mg (4 x 5 mg) dose under…
- Trial name
- NCT00650481
- Testing
- Oxybutynin Chloride Extended-release Tablets 5 mg, Ditropan XL® Tablets 5 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed conditions.
- Trial name
- NCT00829530
- Testing
- Ramipril 10 mg capsule, Altace® 10 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of…
- Trial name
- NCT00415844
- Testing
- ELC200 (carbidopa+levodopa+entacapone)
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis
Healthy
Bioequivalence Study of Letrozole 2.5 mg Tablets
Bioequivalence
- Trial name
- NCT01084499
- Testing
- Femara (Sequence 1), Peratra (Sequence 1), Femara (Sequence 2)
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Fed
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory…
- Trial name
- NCT01505998
- Testing
- Amlodipine Besylate/Benazepril HCl
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes Mellitus
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg…
- Trial name
- NCT02060201
- Testing
- Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01257516
- Testing
- Pregabalin immediate release, 300 mg, Pregabalin controlled release, 330 mg
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
- Trial name
- NCT00849797
- Testing
- Oxcarbazepine, Trileptal®
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in healthy subjects under fasting condition
- Trial name
- NCT00778115
- Testing
- Loperamide HCl 2 mg and simethicone 125 mg tablets
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects…
- Trial name
- NCT00840840
- Testing
- 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL, Augmentin ES-600™
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Overweight, Obesity
A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity.
- Trial name
- NCT04012255
- Testing
- Semaglutide (administered by DV3396 pen), Semaglutide (administered by PDS290 pen)
- Where
- 2 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Novo Nordisk A/S
Bioequivalence
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.
- Trial name
- NCT05197517
- Testing
- Rosuvastatin 10 mg
- Where
- Egypt
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Rania Mahmoud Mohamed
Healthy
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under 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 fasting conditions
- Trial name
- NCT00864058
- Testing
- Gabapentin 400 mg capsules, NEURONTIN® 400 mg capsules
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Pulmonary Arterial Hypertension
Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities
The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.
- Trial name
- NCT01165476
- Testing
- Treprostinil diethanolamine
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- United Therapeutics
Rhinitis, Allergic, Perennial
Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)
This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation…
- Trial name
- NCT00779740
- Testing
- mometasone furoate
- Volunteers
- 102 people
- Sponsor
- Organon and Co
Alzheimer's Disease
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers
- Trial name
- NCT00468897
- Testing
- RSG XR
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets…
- Trial name
- NCT01365091
- Testing
- Saxagliptin/metformin fixed-dose combination (FDC), Saxagliptin, Metformin extended-release (XR)
- Where
- Brazil
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence Study in Healthy Subjects
Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment
This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under…
- Trial name
- NCT07464340
- Testing
- Rivastigmine TDS 9,5 mg/24 h, Exelon® 9.5 mg/24 h
- Where
- Brazil
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
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