Clinical trials: Therapeutic Equivalency
Healthy Volunteers
Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
- Trial name
- NCT06801418
- Testing
- Adagrasib
- Where
- 3 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Mirati Therapeutics Inc.
Anxiety Disorders
Bioequivalence Trial of Alprazolam 0.5 mg Tablets
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg (Pharmacia \& Upjohn).
- Trial name
- NCT01745562
- Testing
- Alprazolam 0.5 mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence of the Test Formulation
Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states
- Trial name
- NCT03496324
- Testing
- Nurofen for Children®, Algifor® Junior
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
Bilateral Cataract
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye.
- Trial name
- TBO (NCT02734459)
- Testing
- cataract surgery
- Volunteers
- 756 people
- Sponsor
- Semler Research Center Pvt. Ltd.
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04400682)
- Testing
- FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novelfarma Ilaç San. ve Tic. Ltd. Sti.
Healthy
Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.
- Trial name
- NCT01132352
- Testing
- Levetiracetam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers
Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female volunteers.
- Trial name
- NIFEPAR_PK1 (NCT02071589)
- Testing
- Nifedipine soft gelatine capsules, Nifedipine oral solution
- Where
- Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Reig Jofre Group
Healthy Adults
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period…
- Trial name
- NCT03898193
- Testing
- Montelukast, Singulair
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
IVIVR Assessing PK Parameters Used to Establish Bioequivalence
The purpose of this study is to determine whether defined and limited changes in in vitro dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of allopurinol and the active metabolite oxypurinol.
- Trial name
- NCT02398448
- Testing
- Zyloprim® 300 mg, Allopurinol 300 mg; undergranulated, high hardness condition, Allopurinol 300 mg; alternative condition 2
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Anti-Infective Agents
Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01105208
- Testing
- Cephalexin suspension (Optocef, BAYO5448 ), Cephalexin suspension (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites
This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites.
- Trial name
- NCT05075876
- Testing
- SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
- Where
- Hong Kong
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Solasia Pharma K.K.
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759915
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers
To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination (FDC) vs. its monocomponents
- Trial name
- NCT02193308
- Testing
- Telmisartan/Amlodipine FDC, Telmisartan, Amlodipine
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Smokers
Nicotine Patch - Bioequivalence Study
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
- Trial name
- NCT02089308
- Testing
- Test treatment : V0116 transdermal patch, Reference treatment : Nicotine transdermal patch
- Where
- France
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.
- Trial name
- NCT01645384
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Psoriasis and Psoriatic Arthritis
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Trial name
- NCT06084663
- Testing
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted…
- Trial name
- NCT00779233
- Testing
- Zidovudine tablets 300 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
- Trial name
- NCT00864604
- Testing
- Nabumetone 750 mg tablets, single dose
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Favipiravir From Flupirava 200 mg Tablet (European Egyptian Pharmaceutical Industries , Egypt) Versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Favipiravir from Flupirava 200 mg tablet (European Egyptian Pharmaceutical Industries, Egypt) versus Avigan 200 mg…
- Trial name
- NCT04478448
- Testing
- Flupirava, Avigan
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
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