Clinical trials: Therapeutic Equivalency, Healthy
Diabetes Mellitus
Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT01358435
- Testing
- 30% Regular Insulin Human Neutral and 70%Isophane Insulin, Novolin 70/30
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.
- Trial name
- NCT00649376
- Testing
- Fexofenadine Tablets 180 mg, Allegra® Tablets 180 mg
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers
- Trial name
- NCT02059915
- Testing
- Oxycodone
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Pain Therapeutics
Healthy
A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma…
- Trial name
- NCT02953535
- Testing
- Magicbuvir, Sovaldi (fist dose), Sovaldi (second dose)
- Where
- Egypt
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Diabetes Mellitus, Type II
Bioequivalence Study for Acarbose / Metformin FDC
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- Trial name
- NCT01728740
- Testing
- Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421), Metformin
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
- Trial name
- NCT01888289
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Cystic Fibrosis
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.
- Trial name
- NCT01953367
- Testing
- Vantobra (tobramycin), TOBI (tobramycin)
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pari Pharma GmbH
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
Bioequivalence Study in Healthy Subjects
Brivaracetam Bioequivalence Assessment
This study assess the relative bioavailability performance of a test brivaracetam coated tablets compared with the EMA reference product, Briviact® 100 mg, in healthy adult volunteers of both sexes under fasting conditions.
- Trial name
- NCT07800533
- Testing
- Briveka ® 100 mg, Briviact® 100 mg
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
Healthy
Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fasting Conditions
The purpose of this study was to determine the bioavailability of benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy fasted subjects.
- Trial name
- NCT00778726
- Testing
- Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline hydrochloride extended release tablets 135 mg…
- Trial name
- NCT02312609
- Testing
- Minocycline hydrochloride
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Donepezil 10 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed conditions.
- Trial name
- NCT01439243
- Testing
- Donepezil, Aricept®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Epilepsy, Tonic-Clonic
Topiramate Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01439438
- Testing
- Topiramate coated tablet, Topamax® coated tablet
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc.
- Trial name
- NCT00650117
- Testing
- Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M), Duragesic 25 mcg/h + Scotch Duct Tape (3M), Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes Mellitus Type 2
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if…
- Trial name
- NCT06766500
- Testing
- Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablets, Synjardy® 5 mg/850 mg film-coated tablets
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Anxiety Disorders
Bioequivalence Trial of Alprazolam 2 mg Tablets
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg (Pharmacia \& Upjohn).
- Trial name
- NCT01745575
- Testing
- Alprazolam 2mg tablets, Alprazolam 2 mg tablets
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence Study in Healthy Subjects
Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations
An open label, randomized, single-dose, two-sequences, two-periods, crossover study to assess the bioequivalence of perampanel in Lepsiramp 0.5mg/ml oral suspension (Test product) in comparison with Fycompa® 0.5mg/ml oral…
- Trial name
- NCT06969963
- Testing
- Lepsiramp, 0.5 Mg/mL Oral Suspension, Fycompa, 0.5 Mg/mL Oral Suspension
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Aya Mohammed Abdel Magid Abdel Hamid
Diabetes
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT00772265
- Testing
- Wosulin N, Novolin N
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fed Condition
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram…
- Trial name
- NCT01996475
- Testing
- Escitalopram Oxalate Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Hepatitis C
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule…
- Trial name
- NCT01181804
- Testing
- boceprevir
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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