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Healthy Adults clinical trials

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NCT ID: NCT01689259 Completed - Healthy Adults Clinical Trials

Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults

Start date: September 2012
Phase: Phase 1
Study type: Interventional

Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).

NCT ID: NCT01634412 Completed - Healthy Adults Clinical Trials

Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

Start date: June 2012
Phase: Phase 1
Study type: Interventional

Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).

NCT ID: NCT01583387 Completed - Healthy Adults Clinical Trials

Effect of Water Intake on the DNA Adducts Formation

Start date: February 2011
Phase: N/A
Study type: Interventional

The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.

NCT ID: NCT01515332 Completed - Healthy Adults Clinical Trials

Energy Expenditure Methodology

Start date: March 2011
Phase: N/A
Study type: Observational

This study is simply to test the repeatability of the indirect calorimetry instrument the investigators use for our clinical studies.

NCT ID: NCT01488747 Completed - Healthy Adults Clinical Trials

Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

Start date: November 2011
Phase: N/A
Study type: Interventional

The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools. The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.

NCT ID: NCT01474226 Completed - Healthy Adults Clinical Trials

Metabolic Availability of Lysine From Rice

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.

NCT ID: NCT01437462 Completed - Healthy Adults Clinical Trials

Sevoflurane, Propofol, Postoperative Pain

Start date: October 2008
Phase: Phase 4
Study type: Interventional

The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.

NCT ID: NCT01402973 Completed - Healthy Adults Clinical Trials

Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products

Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to determine whether it is feasible to conduct a randomized, controlled dietary intervention trial of high versus low dietary intake of advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the impact of high versus low AGE diet health parameters. The investigators hypothesize that it will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a pilot study involving 24 subjects.

NCT ID: NCT01367535 Completed - Healthy Adults Clinical Trials

Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Start date: March 2006
Phase: Phase 1
Study type: Interventional

This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

NCT ID: NCT01366365 Completed - Healthy Adults Clinical Trials

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Start date: October 2006
Phase: Phase 1
Study type: Interventional

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.