Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853216
- Testing
- Oxycodone hydrochloride tablet 30 mg, Roxicodone™ tablet 30 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Postmenopause
Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
- Trial name
- NCT00380887
- Testing
- Premarin
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Gouty Arthritis (GA)
A Bioequivalence Study of Two Different Dosage Form of Genakumab
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
- Trial name
- NCT06451848
- Testing
- Genakumab Injection (T, Solution for injection), Genakumab for Injection (R, Powder for solution for injection)
- Where
- China
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol…
- Trial name
- NCT05300087
- Testing
- Albuterol Sulfate Inhalation Aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition
The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc.…
- Trial name
- NCT01161134
- Testing
- Meloxicam
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Therapeutic Equivalency
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma…
- Trial name
- AZA (NCT03930264)
- Testing
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Healthy Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg…
- Trial name
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy Adult Participants
A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.
- Trial name
- NCT03437564
- Testing
- Vortioxetine
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Takeda
Bioequivalence
Bioequivalence of Amphotericin B Liposome for Injection
The main purpose of this study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.
- Trial name
- NCT05913921
- Testing
- Amphotericin B liposome for injection, AmBisome
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Chinese Healthy Volunteers
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to…
- Trial name
- NCT02196805
- Testing
- Group A: imported Probucol ( Lorelco), Group B: Marketed Probucol ( Chang Tai)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Otsuka Beijing Research Institute
Healthy
Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fed conditions.
- Trial name
- NCT01124175
- Testing
- Losartan, Cozaar®
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Evaluating the Bioequivalence of HIP1302, HGP1406
The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.
- Trial name
- NCT02545829
- Testing
- HIP1302, HGP1406
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy
Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable…
- Trial name
- NCT00778661
- Testing
- amoxicillin 400mg + clovalunic acid 57.5mg tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Pain
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
- Trial name
- NCT02549469
- Testing
- Naproxen Sodium ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC, Naproxen Sodium ER (BAY117031), 40% HPMC
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules…
- Trial name
- NCT00759954
- Testing
- morphine sulfate sustained-release capsules, KADIAN (morphine sulfate sustained-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals…
- Trial name
- NCT00778401
- Testing
- Gabapentin tablets 800 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829712
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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