Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
- Trial name
- NCT00650052
- Testing
- Zonisamide Capsules 100 mg, Zonegran® Capsules 100 mg
- Where
- United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions
- Trial name
- NCT01161940
- Testing
- Nizatidine, Axid
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Asthma
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
- Trial name
- NCT01766843
- Testing
- Seretide Diskus and charcoal, Seretide Diskus, SF Easyhaler and charcoal
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
Topiramate 25 mg Tablets Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting conditions.
- Trial name
- NCT00905606
- Testing
- Topiramate Tablets, Topamax® Tablets
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets
The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version…
- Trial name
- NCT03100838
- Testing
- Nifedipine 60 MG Extended Release Oral Tablet, omeprazole/sodium bicarbonate, SmartPill (TM)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Bioequivalence Study
Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets in Chinese Healthy Volunteers
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
- Trial name
- NCT05794919
- Testing
- Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g, Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Beijing Tongren Hospital
Healthy Volunteers
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are…
- Trial name
- NCT02723630
- Testing
- Lenvatinib 10 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Bioequivalence
Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers
This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.
- Trial name
- NCT04536415
- Testing
- Oseltamivir Phosphate 75 mg capsules, Tamiflu capsules 75 mg
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Austarpharma, LLC
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.
Healthy
Bioequivalence Study of Glimepiride 1mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 1 mg tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets following a single oral dose (1 x 1 mg tablet) in…
- Trial name
- NCT00776490
- Testing
- Glimepiride 1mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg
The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following…
- Trial name
- NCT00730197
- Testing
- Albuterol Sulfate Extended-Release Tablets 8 mg, VoSpire® ER Tablets 8 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Ivermectin Solution Bioequivalence Study - With Food
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference…
- Trial name
- NCT00921674
- Testing
- ivermectin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Hypertension
Bioequivalence Study in Healthy Subjects
This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1…
- Trial name
- NCT00844324
- Testing
- Candesartan cilexetil
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Menopause, Healthy
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA)…
- Trial name
- NCT01596010
- Testing
- 2 mg estradiol / 1 mg norethisterone acetate (NETA)
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.
The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry.
- Trial name
- NCT05027646
- Testing
- Sancuso - Part 1, Sancuso - Part 2
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin, Inc.
Prostatic Hyperplasia
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
A bio-equivalence of 2 different capsule formulations in fasted subjects
- Trial name
- NCT02417831
- Testing
- tamsulosin capsules, tamsulosin HCl
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Tumors
A SHR-1210 BE Study on Healthy Subjects
The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes.
- Trial name
- NCT05799183
- Testing
- SHR-1210
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Cefadroxil 500 mg Capsules Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company)…
- Trial name
- NCT00834275
- Testing
- Cefadroxil 500 mg Capsules, DURICEF® capsules 500 mg
- Where
- 2 sites in United States, Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence
Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women
Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects.
- Trial name
- NCT02592031
- Testing
- XM17, Gonal-f®, Zoladex®
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Merckle GmbH
Healthy
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
The study will aim to evaluate the following: Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100. How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
- Trial name
- NCT02955953
- Testing
- LY2963016
- Where
- Singapore
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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