Clinical trials: Therapeutic Equivalency
Health Volunteer
A Bioequivalence Study of JS005 Pre-filled Syringe and JS005 Auto-injector
This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects.
- Trial name
- NCT06732973
- Testing
- JS005
- Where
- China
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Healthy
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under fasted condition.
- Trial name
- NCT04204902
- Testing
- Tepotinib 100 mg, Tepotinib 250 mg
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT02322658
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions
This is a bioequivalence study to compare Capozide (test product [T]) to ACE-Hemmer-ratiopharm (reference product[R]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions.
- Trial name
- NCT04964050
- Testing
- Capozide, ACE-Hemmer-Ratiopharm
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding
This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose…
- Trial name
- NCT00806078
- Testing
- quinine sulfate
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Bioequivalence
Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg
Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions.
- Trial name
- NCT05145608
- Testing
- Lamotrigine ER tablet 50mg
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.
Open-angle Glaucoma, Ocular Hypertension
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
- Trial name
- NCT06267274
- Testing
- Bimatoprost Ophthalmic Solution, 0.01%, LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
- Where
- 4 sites in United States
- Volunteers
- 240 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Healthy
Levetiracetam 750 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 Levetiracetam tablets versus the reference Keppra® administered as a 1 x 750 mg tablet under fed conditions.
- Trial name
- NCT00849485
- Testing
- Levetiracetam, Keppra®
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Facial Rosacea
Bioequivalence Study of Ivermectin Cream 1% in Treatment of Moderate to Severe Facial Rosacea
To evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Zydus Worldwide DMCC) and Soolantra® (ivermectin) cream, 1% (Galderma Laboratories, L.P.) in the treatment of moderate to severe facial papulopustular…
- Trial name
- NCT04106726
- Testing
- Soolantra® Ivermectin cream 1%, Ivermectin cream 1%
- Where
- 11 sites in United States
- Volunteers
- 525 people
- Sponsor
- Zydus Worldwide DMCC
Healthy Volunteers
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
- Trial name
- NCT06254235
- Testing
- The test octreotide microsphere, The reference octreotide microsphere
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy…
- Trial name
- NCT01053338
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75 mg.
- Trial name
- NCT05083325
- Testing
- Oseltamivir 75mg Test Drug capsules, Oseltamivir 75mg capsules Reference Product capsules
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
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
Therapeutic Equivalency
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
This study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 subjects.
- Trial name
- NCT05282940
- Testing
- Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Microgynon CD
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840411
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Contraception, Contraception, Postcoital
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods.
- Trial name
- LEVEQ-2 (NCT01096498)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028/Opxion), Levonorgestrel (Postday)
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions
The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd.
- Trial name
- NCT00835393
- Testing
- Pantoprazole Sodium 40 mg delayed-release tablets, PROTONIX® 40 mg delayed-release tablets.
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Glaucoma, Open Angle or Ocular Hypertension
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM
- Trial name
- NCT03896633
- Testing
- brinzolamide 1% ophthalmic suspension, Azopt 1%
- Where
- United States
- Volunteers
- 637 people
- Sponsor
- Bausch & Lomb Incorporated
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
Healthy
Buspirone Hydrochloride 30mg Tablets, Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd.
- Trial name
- NCT00840606
- Testing
- BUSPAR® 30 mg Tablet, Buspirone Hydrochloride 30 mg Tablet
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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