Clinical trials: Therapeutic Equivalency
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company…
- Trial name
- NCT01247285
- Testing
- Fluoxetine Hydrochloride, PROZAC WEEKLY®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Allergic Contact Dermatitis
Bioequivalence of Ethylenediamine Dihydrochloride Study
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
- Trial name
- NCT01798589
- Testing
- Ethylenediamine dihydrochloride allergen patch
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Allerderm
Healthy
Relative Bioavailability of 2 Oral Formulations of Nintedanib
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib
- Trial name
- NCT02572752
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5…
- Trial name
- NCT01192152
- Testing
- saxagliptin, Glucophage XR, saxagliptin + metformin XR (FDC tablet)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
- Trial name
- NCT00944450
- Testing
- Sitagliptin phosphate anhydrous formulation, Comparator: sitagliptin phosphate monohydrate form
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc.
- Trial name
- NCT00829790
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to…
- Trial name
- NCT00897390
- Testing
- Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fed conditions.
- Trial name
- NCT00841659
- Testing
- Paroxetine HCl, Paxil®
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Famciclovir 500 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions.
- Trial name
- NCT00834444
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
- Trial name
- NCT02129192
- Testing
- Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hypercholesterolemia
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917579
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Myelodysplastic Syndrome, Myelofibrosis
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold…
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT01290302
- Testing
- Luitpold Azacitidine, Vidaza®
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- American Regent, Inc.
Healthy
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female…
- Trial name
- NCT01020877
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Diarrhea
Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day…
- Trial name
- NCT02498418
- Testing
- Rifaximin, Xifaxan®
- Where
- United States
- Volunteers
- 739 people
- Sponsor
- Actavis Inc.
Healthy
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition.
- Trial name
- NCT00960687
- Testing
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid…
- Trial name
- NCT00961259
- Testing
- Fenofibric Acid 35 mg Tablet, Fenofibric Acid 105 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Advanced Solid Tumors, Solid Tumors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft…
- Conditions
- Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04672460
- Testing
- TALZENNA capsule, Talazoparib soft gel capsule
- Where
- 31 sites in United States, Australia
- Volunteers
- 73 people
- Sponsor
- Pfizer