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Absorption; Chemicals clinical trials

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NCT ID: NCT05328271 Completed - Clinical trials for Absorption; Chemicals

A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion

BBA
Start date: November 20, 2020
Phase: N/A
Study type: Interventional

Think of this section as your research "elevator pitch." Please briefly describe the question(s) or issues you are addressing with your research (limited to 100 words). You will be able to provide information on specific outcomes, hypothesis, or related analysis in a following question. Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to determine the bioavailability of different doses of orally ingested beta-aminoisobutyric acid (BAIBA).

NCT ID: NCT05277376 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic (PK) Evaluation of Bemotrizinol (6%) in a Sunscreen Maximum Usage Trial

Start date: March 15, 2022
Phase: Phase 3
Study type: Interventional

An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.

NCT ID: NCT05076890 Completed - Clinical trials for Absorption; Chemicals

Hemp 15 mg & 50 mg Capsule Absorption

Start date: August 26, 2021
Phase: N/A
Study type: Interventional

This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.

NCT ID: NCT05032807 Completed - Clinical trials for Absorption; Chemicals

Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation

CLIP
Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules. The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness. One way to reduce the food effect and improve bioavailability is to use lipid excipients. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before. The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.

NCT ID: NCT04355286 Completed - Sunscreening Agents Clinical Trials

Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study

BEMT
Start date: November 3, 2020
Phase: Phase 1
Study type: Interventional

This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study). Part 1 is an open-label, 1-arm study in 14 healthy adult subjects with the following primary objectives: - Primary: To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation including 6% BEMT into the systemic circulation when applied under maximal-use conditions. - Secondary: To obtain information needed for a successful pivotal study such as preliminary pharmacokinetic (PK) data, validation of study and analytical procedures, and the number of subjects needed. Part 2 is an open-label, randomized, 3-arm study in 42 healthy adult subjects with the following objective: • Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.

NCT ID: NCT04078646 Completed - Metabolism Clinical Trials

Influence of Proteins on the Bioavailability of Carotenoids

CAROPROT
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

A postprandial intervention study is conducted on healthy male subjects to evaluate whether the addition of proteins (why protein isolate, soy protein) can help to increase the bioavailability of carotenoids from a tomato/carrot beverage.

NCT ID: NCT03807050 Completed - Clinical trials for Absorption; Chemicals

Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties. Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12 healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label, non-randomized, single-dose study. Subjects are admitted to the clinical research center on the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma sampling is performed, then they receive a fat balanced breakfast followed by a single administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours post-dose. Blood for antioxidant activity assessment is also drawn.

NCT ID: NCT03433040 Completed - Premature Birth Clinical Trials

17OHP-C Dosing Among Obese Pregnant Women

Start date: August 23, 2017
Phase: Phase 3
Study type: Interventional

Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.