Clinical trials: Bioavailability Study
Acquired Immunodeficiency Syndrome, HIV Infections
A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children With HIV Infection
This is a phase I/II study to determine the safety and tolerance of the protease inhibitor indinavir (MK-0639), alone and then in combination with HIV reverse transcriptase inhibitor therapy in children with HIV infection.
- Trial name
- NCT00001443
- Testing
- indinavir (MK-0639)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- National Cancer Institute (NCI)
Nausea, Vomiting
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
The primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.
- Conditions
- Nausea, Vomiting, Chemotherapy
- Trial name
- NCT01249001
- Testing
- Oral Aprepitant, Aprepitant
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- The Hospital for Sick Children
Pain
Methadone Pharmacokinetics and Cardiac Effects in Newborns
The Primary objectives of this proposal are to determine the population kinetics for methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post menstrual age (PMA) who are 1 week old and older and…
- Trial name
- NCT00715988
- Testing
- Methadone HCl Inject 10 mg/ml (will require dilution), Methadone
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- University of Utah
Pneumonia, Pneumocystis Carinii, HIV Infections
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily…
- Trial name
- NCT00000773
- Testing
- Atovaquone
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Iron Bioavailability
Baby Iron Bioavailability Study
The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
- Trial name
- NCT03754543
- Testing
- Labeled iron salt Fe54, Labeled iron salt Fe57, Labeled iron salt Fe58
- Where
- Malawi
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Graft Versus Host Disease, Stem Cell Transplantation
Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease
Determine how much voriconazole is absorbed when the product is given by mouth to children with extensive graft versus host disease after a stem cell transplantation and determine the correct dosing of voriconazole in this…
- Trial name
- NCT00792246
- Testing
- voriconazole
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Phillip Brian Smith
Cystic Fibrosis
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
The purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.
- Trial name
- NCT02646995
- Testing
- modified lipid formulation, Fish oil
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Société des Produits Nestlé (SPN)
Acne Vulgaris
A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%.
- Trial name
- NCT01019603
- Testing
- Tazarotene, Tazaroc Gel
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stiefel, a GSK Company
Asthma
Impact of Anti-static Chamber/Mask
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.
- Trial name
- NCT00307970
- Testing
- HFA FP MDI, conventional chamber/mask; anti-static chamber/mask
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Sickle Cell Anemia
Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia
Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with sickle cell anemia.
- Trial name
- HU (NCT01506544)
- Testing
- Hydroxyurea
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Children's Mercy Hospital Kansas City
Recurrent Prostate Cancer, Stage IV Prostate Cancer
Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen
RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer.
- Trial name
- NCT01682941
- Testing
- Arm I Soy Bread, Arm II Soy-Almond Bread
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Procedural Sedation
Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or…
- Trial name
- PINDEX (NCT02955732)
- Testing
- Dexmedetomidine
- Where
- Finland
- Volunteers
- 50 people
- Sponsor
- Turku University Hospital
Type 2 Diabetes
Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects
The objective of this study is to evaluate the relative bioavailability, and the rate and extent of absorption of bromocriptine in male and female children and adolescent Type 2 Diabetes Mellitus patients, aged 10 to less than…
- Trial name
- NCT02078440
- Testing
- Bromocriptine mesylate
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- VeroScience
Dental Caries, Dental Fluorosis
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis.
- Trial name
- NCT01589991
- Testing
- Toothpaste
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Campinas, Brazil
Environmental Enteric Dysfunction
Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)
In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011.
- Trial name
- IAA-EED (NCT07256028)
- Testing
- Indispensable amino acids supplemntation, Without Indispensable amino acids supplementation
- Where
- Morocco
- Volunteers
- 40 people
- Sponsor
- Morocco's National Centre for Energy, Sciences and Nuclear Techniques
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
A CFit Study - Acute Exercise
A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research aiming to maximise the quality of life (QoL) of the aging CF…
- Trial name
- NCT03237767
- Testing
- MIE, HIIE
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- University of Portsmouth
Iron Absorption
Iron Bioavailability of Fortified Oat Drink
This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable…
- Trial name
- NCT01423162
- Testing
- Dietary Intervention (with Vit C then without Vit C), Dietary Intervention (without Vit C followed by with Vit C)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Iron Absorption, Iron Deficiencies
Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia.
- Conditions
- Iron Absorption, Iron Deficiencies, Severly Acutely Malnourished Children, Malnutrition in Children
- Trial name
- SAMI (NCT07315295)
- Testing
- Iron absorption from RUTF on Day 0, Treatment with RUTF for 80 days, Iron absorption from RUTF on Day 20
- Where
- 2 sites in Kenya, Switzerland
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- ETH Zurich
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
Acne Vulgaris
W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne
This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben.
- Trial name
- NCT01132443
- Testing
- Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,
- Volunteers
- 72 people
- Sponsor
- Stiefel, a GSK Company