Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi…
- Trial name
- NCT01630642
- Testing
- Torrent's Clopidogrel Tablets USP 75 mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence
A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects
The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO Retard (isosorbide -5 -mononitrate extended…
- Trial name
- NCT03557580
- Testing
- IS-5-MN R, IS-5-MN T1, IS-5-MN T2
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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.
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in…
- Trial name
- NCT02297854
- Testing
- Valganciclovir Hydrochloride
- Where
- India
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteer
The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions
Objective: Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7…
- Trial name
- NCT06228339
- Testing
- Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy, Healthy Donors
Bioequivalence Study of Revolade® Eltrombopag 50 mg
Bioequivalence Study
- Trial name
- Eltrombopag (NCT06834451)
- Testing
- Revolade®, Eltrombopag (EPAG)
- Where
- Colombia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Healthy
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female…
- Trial name
- NCT01020877
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Type 2 Diabetes Mellitus
Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy Subjects
In this integrated, Phase I study, the safety, tolerability, food effect, and pharmacokinetic (PK) properties of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR…
- Trial name
- NCT03138356
- Testing
- 2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet, 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet, 5 mg dapagliflozin / 850 mg metformin XR FDC
- Where
- United Kingdom
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Fed
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503450
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02327247
- Testing
- Felodipine, PLENDIL®
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being…
- Trial name
- NCT01906125
- Testing
- palbociclib capsule: phase 1 and 2 studies, Palbociclib capsule: phase 3 studies, Palbociclib capsule: ICH
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pharmacokinetics
Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects
This study was designed to assess the bioequivalence of single oral dose of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Versus Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH…
- Trial name
- NCT05125640
- Testing
- Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine), Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
- Where
- Jordan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Cetuximab, Bioequivalence
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects
- Conditions
- Cetuximab, Bioequivalence, Healthy Volunteers, Pharmacokinetics
- Trial name
- BT-HC034S-101 (NCT07813468)
- Testing
- HC034S, Erbitux (Cetuximab)
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- HC Biopharma Inc.
Lung Cancer, Oral Cancer
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared…
- Conditions
- Lung Cancer, Oral Cancer, Melanoma
- Trial name
- EDDIS-a1 (NCT06897735)
- Testing
- Afatinib Dimaleat, inhalation of afatinib dimaleate
- Where
- New Zealand
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Petrov, Andrey
Healthy
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition.
- Trial name
- NCT00960687
- Testing
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fasting 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
- NCT02312297
- Testing
- Minocycline hydrochloride
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Lu AF35700
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
- Trial name
- NCT03394482
- Testing
- Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Healthy Adults
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions
The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.
- Trial name
- NCT07587697
- Testing
- Tafamidis
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
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