Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fed Conditions
The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL)…
- Trial name
- NCT00778739
- Testing
- CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
- Trial name
- NCT01330472
- Testing
- Xanax XR tablets 3 mg (sourced from Caugus), Xanax XR tablets 3 mg (sourced from Barceloneta)
- Where
- Singapore
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence
Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days
- Trial name
- NCT02974439
- Testing
- LANDI-Amlodipine Besylate Tablet 5mg, Norvasc Tablets 5mg
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Haini Pharmaceutical Co., Ltd.
Healthy
Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants
This study investigated the bioequivalence and drug-drug interaction of Metformin/Gliclazide fixed combination tablet compared to co-administration of individual tablets of Metformin and Gliclazide.
- Trial name
- NCT03467945
- Testing
- Metformin/Gliclazide Fixed Combination, Metformin, Gliclazide
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled…
- Trial name
- NCT04840901
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Fed
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735383
- Testing
- Etodolac Tablets USP 500mg, Etodolac Tablets USP 500 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
- Trial name
- NCT02171013
- Testing
- Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%), Dabigatran polymorph I
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects
In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately.
- Trial name
- NCT06180720
- Testing
- Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Post-operative Pain, Bioequivalence Study in Healthy Subjects
Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of parecoxib after intravenous bolus of parecoxib in healthy volunteers under fasting conditions
- Trial name
- NCT06600282
- Testing
- Parecoxib
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects…
- Trial name
- NCT01645410
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101308
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Type 2 Diabetes Mellitus
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
- Trial name
- NCT00944450
- Testing
- Sitagliptin phosphate anhydrous formulation, Comparator: sitagliptin phosphate monohydrate form
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI)…
- Trial name
- NCT04661397
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Acute Lymphoblastic Leukemia
Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions
The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent.
- Trial name
- NCT01697020
- Testing
- Mercaptopurine 20mg/ml oral suspension, Mercaptopurine 50mg tablet
- Where
- South Africa
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Bioequivalence
Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg
The objective of this study is to determine the bioequivalence of 2 different formulations of bupropion after a single oral dose administration under fasting conditions.
- Trial name
- NCT05160090
- Testing
- Bupropion HCl MR tablets 300mg
- Where
- 2 sites in Canada
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.
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
Healthy
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20…
- Trial name
- NCT00649597
- Testing
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Lotensin HCT® Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on After Meals in Healthy Subjects
In order to evaluate the bioequivalence of the test preparation and reference preparation of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
- Trial name
- NCT04556110
- Testing
- Perindopril tert-Butylamine tablets （ Produced by Haisco）, Perindopril tert-Butylamine tablets（ACERTIL®）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy
Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc.
- Trial name
- NCT01074450
- Testing
- Pramipexole Dihydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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