Clinical trials: Therapeutic Equivalency, Healthy
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.
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
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
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
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
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
Therapeutic Equivalency
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or…
- Trial name
- NCT01436526
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for…
- Trial name
- NCT00648271
- Testing
- Metoprolol Tartrate Tablets 25 mg, Lopressor® Tablets 50 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.
- Trial name
- NCT05581693
- Testing
- L04RD1, L04TD2
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
Bioequivalence, Healthy Japanese Subjects
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects
This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.
- Conditions
- Bioequivalence, Healthy Japanese Subjects, Pharmacokinetics
- Trial name
- NCT02436577
- Testing
- Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy…
- Trial name
- NCT00648557
- Testing
- Levothyroxine Sodium Tablets 200 mg, Synthroid Tablets 200 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
- Trial name
- NCT00864565
- Testing
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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