Clinical trials: Therapeutic Equivalency
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
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.
Healthy
Valacyclovir 1000 mg Tablet Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.
- Trial name
- NCT01149460
- Testing
- Valacyclovir
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Primary Ovarian Insufficiency, Vaginitis
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Trial name
- NCT01436513
- Testing
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed)
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pharmacokinetics
Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects
This study was designed to assess the bioequivalence of single oral dose of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Versus Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH…
- Trial name
- NCT05125640
- Testing
- Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine), Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
- Where
- Jordan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Hypertension
Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02186496
- Testing
- CKD-330 8/5mg, Candesartan 8mg and Amlodipine 5mg
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fasting Condition
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets (Reference formulation; Eli Lilly and…
- Trial name
- NCT01996488
- Testing
- Olanzapine Orally Disintegrating Tablets 5mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Prostate Cancer, Hirsutism
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions
The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.
- Trial name
- NCT00960310
- Testing
- Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA), Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sandoz
Eye Infections, Postoperative Complications
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic…
- Trial name
- NCT00198523
- Testing
- Prednisolone and Tobramycin, Prednisolone
- Where
- 6 sites in United States
- Volunteers
- 132 people
- Sponsor
- Bausch & Lomb Incorporated
Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
- Trial name
- 01905/08-09 (NCT01217190)
- Testing
- Ondansetron (ODFS), Zofran (ODT)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MonoSol Rx
Bioequivalency
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting Conditions
Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a single, one-tablet dose in fasted subjects.
- Trial name
- NCT00804440
- Testing
- Ibuprofen Tablets, 800 mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Perrigo Company
Head Lice
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
- Trial name
- NCT03337490
- Testing
- Ivermectin 0.5% Topical Application Lotion, Ivermectin 0.5% Topical Application Lotion [SKLICE]
- Where
- 6 sites in United States
- Volunteers
- 296 people
- Sponsor
- Mayne Pharma International Pty Ltd
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