Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation
1 other identifier
interventional
10
1 country
1
Brief Summary
The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedStudy Start
First participant enrolled
December 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2020
CompletedDecember 19, 2018
December 1, 2018
2 years
December 3, 2018
December 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls
Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine
From 2 weeks up til 5 weeks
Secondary Outcomes (2)
Blood pressure in response to Nitroglycerine
From 2 weeks up til 5 weeks
Puls rate in response to Nitroglycerine
From 2 weeks up til 5 weeks
Study Arms (1)
"NTG1523", rapid absorbable capsule
EXPERIMENTALNitroglycerine 0.4 milligram taken as ordinary tablets or "NTG1523" rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed
Interventions
The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel "NTG1523" determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Eligibility Criteria
You may qualify if:
- Normal healthy volunteers
- Must be able to swallow tablets
You may not qualify if:
- Insulin dependent diabetes
- Thyroid disease
- any medial treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kolding Sygehuslead
Study Sites (1)
Kolfding Sygehus, SLB
Kolding, 6000, Denmark
Related Publications (2)
Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.
PMID: 2111749BACKGROUNDMcAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.
PMID: 3085698RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ole W Rasmussen, M.D. Dr.Sci
Medical Dept.,Kolding Hospital, SLB, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All tablets are processed, marked and coded by a pharmacist,
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
December 3, 2018
First Posted
December 17, 2018
Study Start
December 23, 2018
Primary Completion
December 5, 2020
Study Completion
December 23, 2020
Last Updated
December 19, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share