Clinical trials: Therapeutic Equivalency
Healthy
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under…
- Trial name
- NCT00835705
- Testing
- amoxicillin-clavulanic acid, Augmentin®
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Anti-Infective Agents
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01073553
- Testing
- Cephalexin capsules (Optocef, BAYO5448 ), Cephalexin capsules (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Advanced Pancreatic Cancer
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
- Trial name
- NCT04482257
- Testing
- Irinotecan Liposome Injection combined with 5-FU/LV
- Where
- China
- Volunteers
- 48 people
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Healthy
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and…
- Trial name
- NCT01463228
- Testing
- A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets), B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x…
- Trial name
- NCT01182194
- Testing
- Drospirenone/Ethinyl Estradiol (Gianvi®), YAZ®
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Adult Subjects
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting…
- Trial name
- NCT06107205
- Testing
- TTYP01, Radicava, Radicava ORS
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
Diabetes Mellitus, Type 2
A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.
- Trial name
- NCT01554631
- Testing
- Acarbose (Glucobay ODT, BAYG5421), Acarbose (Glucobay, BAYG5421)
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions
- Trial name
- NCT01131975
- Testing
- Lamotrigine
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Parkinson Disease
Relative Bioavailability and Bioequivalence of Opicapone
the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting…
- Trial name
- NCT03820037
- Testing
- Ongentys, BIA 9-1067 (test)
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hypertension
A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg in healthy adult volunteers
- Trial name
- NCT05223101
- Testing
- Telminone 80 mg, Drug: Micardis 80 mg
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Hypercholesterolaemia
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals.
- Trial name
- NCT01597700
- Testing
- 10mg Ezetimibe, 10 mg Ezetimibe - wash out period
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Therapeutic Equivalency
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
- Trial name
- NCT01405131
- Testing
- methylprednisolone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
- Trial name
- NCT02187575
- Testing
- UHAC 62 XX tablet, UHAC 62 XX capsule
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation
The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01523236
- Testing
- Mometasone furoate, Nasonex®
- Volunteers
- 800 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233097
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Fasting Study of Doxycycline Monohydrate Tablets 150 mg and Adoxa Tablets 150 mg
The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 150 mg tablets to Par's Adoxa® 150 mg tablets following a single, oral 150 mg (1 x 150 mg) dose administered under fasting…
- Trial name
- NCT00647959
- Testing
- Doxycycline Tablets, 150mg, Adoxa Tablets 150 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Type 2 Diabetes Mellitus
Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects
In this integrated, Phase I study, the safety, tolerability, food effect, and pharmacokinetic (PK) properties of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR…
- Trial name
- NCT03138356
- Testing
- 2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet, 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet, 5 mg dapagliflozin / 850 mg metformin XR FDC
- Where
- United Kingdom
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Bioavailability of Clotiazepam 5 mg With Regards to Reference Product
This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet formulations containing Clotiazepam 5 mg. The Pivotal study will be performed at a single site with 30 subjects.
- Trial name
- NCT04440423
- Testing
- Clotiazepam 5 mg Test Product Coated Tablets, Clotiazepam 5 mg Reference Product Coated Tablets
- Where
- Chile
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
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