scholarly journals Safety Assessment of Oral 5-aminolevulinic Acid and Ferrous iron in Healthy Human Subjects: A Non-randomized, Open-label, Non-placebo-controlled Trial

2021 ◽  
Author(s):  
Hidenori Ito ◽  
Tohru Tanaka
Keyword(s):  
Safety Assessment ◽  
Aminolevulinic Acid ◽  
Human Subjects ◽  
Controlled Trial ◽  
Elevated Serum ◽  
Food Supplement ◽  
Open Label ◽  
Healthy Human ◽  
Ferrous Citrate ◽  
Combined Administration

Abstract The combination of 5-aminolevulinic acid (5-ALA) phosphate and sodium ferrous citrate (SFC) has been approved as an ingredient of food supplement in several countries because of its wide applicability to healthcare areas. We aimed to assess the safety of 5-ALA phosphate and SFC in healthy adult subjects at the dose several times higher than that available on market. This was an open, non-randomized, non-placebo-controlled trial that included 11 men and 11 women. Doses of 250 mg 5-ALA phosphate and 143.4 mg SFC (15 mg as Fe) per day were orally administered for 28 days. Blood and urine analyses and interviews were conducted to assess the safety. No test compound-related adverse events or abnormal values were observed, except for elevated serum iron levels, which were mild to moderate and transient. Combined administration of 5-ALA phosphate and SFC to healthy adults is well-tolerated and safe at the dose and duration investigated in this study.

The DGAT1 inhibitor pradigastat does not induce photosensitivity in healthy human subjects: a randomized controlled trial using three defined sunlight exposure conditions

2016 ◽  
Vol 15 (9) ◽  
pp. 1155-1162 ◽  
Author(s):  
Daniel Bauer ◽  
Rachel L. Soon ◽  
Kenneth Kulmatycki ◽  
Yuming Chen ◽  
Adele Noe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Human Subjects ◽  
Controlled Trial ◽  
Sunlight Exposure ◽  
Preclinical Studies ◽  
Healthy Human ◽  
Randomized Controlled ◽  
Healthy Human Subjects ◽  
Exposure Conditions

The DGAT1 inhibitor, pradigastat, demonstrated a mild phototoxicity signal in preclinical studies.

scholarly journals A Comparative Pharmacokinetic Evaluation of a Bioavailable Curcumin Formulation Curene® with Curcumin Formulation Containing Turmeric Volatile Oil and Standard Curcuminoids 95% in Healthy Human Subjects

2019 ◽  
Vol 9 (2) ◽  
pp. 134
Author(s):  
Sanjib Kumar Panda ◽  
Somashekara ◽  
Vivek A. Parachur ◽  
Nilima Mohanty ◽  
Tathastu Swain ◽  
...  
Keyword(s):  
Human Subjects ◽  
Health Benefits ◽  
Volatile Oil ◽  
Relative Bioavailability ◽  
Healthy Male ◽  
Open Label ◽  
Healthy Human ◽  
Comparative Pharmacokinetic ◽  
Reference Treatment ◽  
Healthy Human Subjects

Background: Curcumin, a major active component of turmeric, which is one of the most studied botanicals for its numerous health benefits and higher safety profile. In spite of its potent clinical health benefits, its applications are circumscribed due to its poor bioavailability. The current study was carried out to compare the oral bioavailbility of newly developed bioavailable curcumin formulation Curene® with Curcumin formulation containing turmeric volatile oil (CP-01) and Standard Curcuminoids 95% in healthy human volunteers.Methods: In this current open-label, randomized, three treatments, single oral dose, single period, parallel, comparative pharmacokinetics study, 12 healthy male volunteers participated. The test product Curene® (T), reference products CP-01(Reference treatment-R1) and Standard Curcuminoids 95% (Reference treatment-R2) were orally administrated as a single dose of 3 grams per subject. Plasma samples were withdrawn from each subject at predetermined timepoints and samples were analyzed by LC-MS/MS. Results: Based on the pharmacokinetics data, the relative bioavailability (Free Curcumin; AUC0-t) of Curene® was found to be ~112.7 times more when compared to the standard Curcuminoids (R2).Conclusion: The oral bioavailability of Curene® was found to be significantly higher compared to CP-01and Standard Curcuminoids (95%) furthermore, it was also found to be safe in healthy human subjects under the study conditions.

Influence of Intranasal Epinephrine and Lidocaine Spray on Olfactory Function Tests in Healthy Human Subjects

2011 ◽  
Vol 145 (6) ◽  
pp. 946-950 ◽  
Author(s):  
Yong Gi Jung ◽  
Seung Yong Ha ◽  
Young-Gyu Eun ◽  
Myung-Gu Kim
Keyword(s):  
Human Subjects ◽  
Controlled Trial ◽  
Study Groups ◽  
Control Group ◽  
Tertiary Referral Hospital ◽  
Healthy Human ◽  
Lidocaine Group ◽  
Olfactory Test ◽  
The Mean ◽  
Double Blinded

Objective. Although topical decongestants and anesthetics are widely used in preparation for nasal endoscopy, no controlled trials have evaluated the effects of these agents on olfaction. Study Design. Randomized double-blinded controlled trial. Setting. Tertiary referral hospital. Materials and Methods. The authors recruited 72 healthy subjects and randomly assigned them to 1 of 4 groups (control, phenylephrine group, lidocaine group, and both agents). After baseline tests with the Korean version of Sniffin’ Stick Test II (KVSS II), topical agents were applied to each nostril. Fifteen minutes later, repeat tests were carried out. Pre- and postspray results of the olfactory tests were compared, and the differences among groups were analyzed. Results. The mean ± SD prespray KVSS II score of the study group was 30.2 ± 3.8, and there were no statistically significant differences among the study groups ( P = .353). Mean ± SD pre- and postspray KVSS II scores were 29.0 ± 3.5 and 30.7 ± 3.7 ( P = .128) in the control group, 30.6 ± 3.6 and 31.7 ± 3.3 ( P = .262) in the phenylephrine group, and 31.4 ± 3.6 and 32.1 ± 3.1 ( P = .557) in the lidocaine group, respectively. In the phenylephrine and epinephrine spray group, the mean ± SD pre- and postspray scores were 29.9 ± 4.4 and 31.3 ± 3.7 ( P = .071), respectively. Conclusions. Neither topical intranasal phenylephrine nor lidocaine use affected the results of the olfactory test, even when the agents were used in combination.

scholarly journals Changes in plasma fibronectin during acute nutritional deprivation in healthy human subjects

1986 ◽  
Vol 55 (1) ◽  
pp. 7-12 ◽  
Author(s):  
S. J. D. Chadwick ◽  
A. J. W. Sim ◽  
H. A. F. Dudley
Keyword(s):  
Human Subjects ◽  
Elevated Serum ◽  
Reticuloendothelial System ◽  
Starvation Period ◽  
Plasma Fibronectin ◽  
Short Term ◽  
Healthy Human ◽  
Rapid Reduction ◽  
Nutritional Deprivation ◽  
Healthy Human Subjects

1. Plasma fibronectin, a glycoprotein, is an opsonin of the reticuloendothelial system.2. In ten healthy volunteers starved for 4.5 d, daily measurements showed a rapid reduction in plasma fibronectin, no alteration in either C3 or plasma transferrin and, at the end of the starvation period, an elevated serum albumin.3. On refeeding, plasma fibronectin rapidly returned to its prestarvation level but plasma transferrin was significantly reduced and did not recover by the end of the study.4. Changes in plasma fibronectin may be a sensitive index of nutritional status. The reduction of plasma fibronectin in short-term starvation may compromise host defence tolerance of injury and sepsis.

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