Clinical trials: Therapeutic Equivalency
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Suspension 250
The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5…
- Trial name
- NCT01767571
- Testing
- Cephalexin 125 mg/5ml, Cephalexin 250mg/5ml
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
- Trial name
- NCT03107611
- Testing
- Pimecrolimus Cream, 1%
- Where
- 27 sites in United States, Dominican Republic and 1 more
- Volunteers
- 654 people
- Sponsor
- Mylan Inc.
Healthy Subjects
Bioequivalence Study of SB797620 in Healthy Japanese Volunteers
This study will test whether the Drug levels in plasma after combination formulation tablet dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to Japanese Healthy volunteer would be the same…
- Trial name
- NCT00549263
- Testing
- SB797620
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Cefprozil for Oral Suspension 250 mg/5 mL, Fasting
The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in…
- Trial name
- NCT00835614
- Testing
- Cefprozil for oral suspension 250 mg/5 mL, CEFZIL® for Oral Suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different…
- Trial name
- NCT02259179
- Testing
- Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets), Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Orexigen Therapeutics, Inc
Healthy
Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects
To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and…
- Trial name
- NCT05841446
- Testing
- test apixaban tablets, reference apixaban tablets
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Diabetes, Diabetes Mellitus, Type 1
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be…
- Trial name
- NCT01455142
- Testing
- insulin degludec/insulin aspart
- Where
- Austria
- Volunteers
- 32 people
- Sponsor
- Novo Nordisk A/S
Arthritis, Rheumatoid
A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550
In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time.
- Trial name
- NCT01277991
- Testing
- Treatment A, Treatment B
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches.
- Trial name
- NCT02171520
- Testing
- Dabigatran etexilate generation I, Dabigatran etexilate generation II
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg…
- Trial name
- NCT02295046
- Testing
- Amlodipine besylate/Atorvastatin calcium
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Fasting Conditions
To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting conditions.
- Trial name
- NCT00864435
- Testing
- Carvedilol 12.5 mg Tablets, single dose, Coreg® 12.5 mg Tablets , single dose
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers
The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.
- Trial name
- NCT03979274
- Testing
- Reference Eutirox®, Test Eutirox®
- Where
- Mexico
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions
The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fed conditions.
- Trial name
- NCT00777413
- Testing
- Minocycline 100mg Tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01691469
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
The objective of this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following by a single, oral 300 mg (1 x 300 mg)…
- Trial name
- NCT00649805
- Testing
- Verapamil Hydrochloride Extended-Release Capsules, 300 mg, Verelan® PM Extended-Release Capsules, 300 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Neoplasms
A Study of DOXIL/CAELYX in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer
The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX.
- Trial name
- NCT02081495
- Testing
- DOXIL/CAELYX reference product (Treatment A), DOXIL/CAELYX test product (Treatment B)
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 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 an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a…
- Trial name
- NCT06340581
- Testing
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Cerebrotendinous Xanthomatoses
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] versus Chenodeoxycholic acid leadiant…
- Trial name
- NCT06180057
- Testing
- Chenodeoxycholic acid, Chenodeoxycholic acid leadiant
- Where
- Jordan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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