Clinical trials: Biological Availability
Healthy
Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted).
- Trial name
- NCT02408068
- Testing
- Dexamethasone, Chronocort: fasted, Immediate release hydrocortisone: fasted
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Heat Effect
PK and DPK of Lidocaine Dermal Products
This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.
- Trial name
- NCT03145207
- Testing
- Lidocaine patch
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy Non-smoker
Matrix on Fruit Constituent Bioavailability
Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.
- Trial name
- FRT (NCT01908634)
- Testing
- Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal, Milk-based strawberry Beverage with meal
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
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.
Healthy
Famciclovir 500 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions.
- Trial name
- NCT00834444
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral…
- Trial name
- NCT03811834
- Testing
- Mobocertinib
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Non-24-Hour-Sleep-Wake Disorder
Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)
Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24). Non-24 is very common in people who are totally blind because light can not reset their body clock.
- Trial name
- NCT02130999
- Testing
- tasimelteon 20 mg capsule, tasimelteon 2 mg I.V.
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult…
- Trial name
- NCT05405985
- Testing
- Nemolizumab
- Where
- 2 sites in United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Healthy
A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.
- Trial name
- NCT03467971
- Testing
- Metformin/Gliclazide Fixed Combination
- Where
- Mexico
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Cefprozil for Oral Suspension 250 mg/5 mL, Fasting
The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in…
- Trial name
- NCT00835614
- Testing
- Cefprozil for oral suspension 250 mg/5 mL, CEFZIL® for Oral Suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioavailability
Bioavailability of Belumosudil (KD025) in Healthy Male Subjects
Phase 1 bioavailability study to evaluate the pharmacokinetics (PK) and tolerability/safety of the belumosudil tablet formulation in the fasted and fed states and compared to the belumosudil capsule formulation in the fed state.
- Trial name
- NCT02557139
- Testing
- Belumosudil Tablet, Belumosudil Capsule
- Where
- United Kingdom
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Kadmon Corporation, LLC
Diabetes Mellitus, Type II
A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.
LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an…
- Trial name
- NCT01301092
- Testing
- LY2189265
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants
The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and…
- Trial name
- NCT06831344
- Testing
- Vonoprazan ODT-1 or ODT-2 without Water, Vonoprazan ODT-1 or ODT-2 with Water, Vonoprazan (Reference)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Phathom Pharmaceuticals, Inc.
Healthy
Mycophenolate Mofetil Tablets Under Fasting Conditions
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a single-dose in healthy subjects under fasting…
- Trial name
- NCT00907907
- Testing
- Mycophenolate Mofetil, CellCept® Tablets
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Nonheme Iron Absorption
Iron Bioavailability From MyPyramid Menus
This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus. Such measurements will confirm whether modifications are needed to meet dietary iron recommendations and will provide data useful for…
- Trial name
- NCT00754234
- Testing
- My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USDA Grand Forks Human Nutrition Research Center
Type 1 Diabetes Mellitus
Lisofylline as Continuous Subcutaneous and Intravenous Administration in Subjects With Type 1 Diabetes Mellitus
The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes.
- Trial name
- NCT01603121
- Testing
- Lisofylline
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Eastern Virginia Medical School
Schizophrenia
An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia
The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body
- Trial name
- NCT01646827
- Testing
- Aripiprazole IM Depot
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd.
- Trial name
- NCT01149486
- Testing
- Losartan potassium/Hydrochlorothiazide, Hyzaar®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc.
- Trial name
- NCT02465866
- Testing
- CL-108, Vicoprofen, Ultracet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
Neoplasms, Advanced Solid
A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors
The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the pharmacokinetics (PK) of TAK-931 as a…
- Trial name
- NCT03708211
- Testing
- TAK-931 PIC, TAK-931 Tablet, Esomeprazole
- Where
- 4 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Millennium Pharmaceuticals, Inc.