Clinical trials: Fasting Conditions
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Disorder of Consciousness, Traumatic Brain Injury
Validity and Feasibility of the CRSR-FAST
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings.
- Trial name
- CRSR-FAST (NCT03549572)
- Testing
- Coma Recovery Scale-Revised
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Massachusetts General Hospital
Healthy
Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
- Trial name
- NCT00836056
- Testing
- Clindamycin 300 mg capsule, Cleocin HCl 300 mg capsules
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Cefprozil 500 mg Tablets Under Fed Conditions
The objective of this study is to compare the relative bioavailability of cefprozil 500 mg tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting conditions.
- Trial name
- NCT00840866
- Testing
- cefprozil, Cefzil®
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Amlodipine 10 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fasting conditions.
- Trial name
- NCT00841542
- Testing
- Amlodipine Besylate, Norvasc®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Therapeutic Equivalency
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma…
- Trial name
- AZA (NCT03930264)
- Testing
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Healthy
Venlafaxine 25 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting conditions.
- Trial name
- NCT00834964
- Testing
- Venlafaxine 25 mg Tablets, Effexor® 25 mg Tablets
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Bioavailability Study of Zonisamide Capsules
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral…
- Trial name
- NCT00685139
- Testing
- Zonisamide 100 mg Capsule, Zonisamide (Zonegran®) 100 mg Capsule
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
Fed Bioavailability Study of Zonisamide Capsules
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a…
- Trial name
- NCT00687167
- Testing
- Zonisamide 100 mg Capsule, Zonisamide (Zonegran®) 100 mg Capsule
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Anxiety Disorders
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China.
- Trial name
- NCT03329573
- Testing
- Paroxetine IR tablets A, Paroxetine IR tablets B
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioavailability Study of Colcrys® in Apple Juice
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact…
- Trial name
- NCT01123395
- Testing
- colchicine 0.6 mg tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Prediabetes
Metformin and Muscle in Insulin-resistant Older Veterans
Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures.
- Trial name
- M&M (NCT01804049)
- Testing
- metformin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VA Office of Research and Development
Healthy
Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-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
- NCT01074463
- Testing
- Pramipexole Dihydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
The objectives of this study were: to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets)…
- Trial name
- NCT01121913
- Testing
- Trazodone HCl
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.
Healthy
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.
- Trial name
- NCT00835263
- Testing
- Lamotrigine, Lamictal®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Cancer Prevention, Weight Loss
PROFAST Intervention in Precursor Multiple Myeloma
This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM)…
- Conditions
- Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS
- Trial name
- PROFAST (NCT05565638)
- Testing
- Prolonged Fasting Intervention, EDUCATION CONTROL
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Dana-Farber Cancer Institute
Healthy
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating…
- Trial name
- NCT01260948
- Testing
- Donepezil Hydrochloride, Aricept®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA