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The Relative Bio-availability of Oral and Oromucosal Melatonin in Different Formulations in Healthy Human Volunteers. (Melaform)

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ClinicalTrials.gov Identifier: NCT02107079
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ingeborg Marianne van Geijlswijk, Utrecht University

Brief Summary:
The circadian rhythm, the sleep-wake cycle, is mainly regulated by melatonin. The synthesis of melatonin is stimulated by the absence of light, leading to peak serum levels before bedtime. In humans, this endogenous "signaling" neurohormone induces sleep. Exogenous melatonin can be beneficial in different sleep disturbances including delayed sleep phase insomnia, melatonin- deficiency-related insomnia (especially in elderly) and shift work sleep disorder. Melatonin is known for its low and variable bioavailability in humans due to a high first pass effect and variable pharmacokinetics and short half-life. In order to prevent exposure of patients with unnecessary high dosages of melatonin and in order to achieve a short Tmax and high bio-availability of melatonin, a proper formulation needs to be defined. This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin for the treatment of insomnia by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after administration of melatonin in different formulations: 2,5mg melatonin immediate release capsule (produced by Apotheek UMCU), 1mg melatonin immediate release tablet (produced by Tiofarma), low-dose 0.1mg melatonin original Sleepzz tablet (produced by Vemedia Manufacturing BV).

Condition or disease Intervention/treatment Phase
Pharmacokinetics of Melatonin Drug: Melatonin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Relative Bio-availability of Oral and Oromucosal Melatonin in Different Formulations in Healthy Human Volunteers. A Three-phased Cross-over Study.
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: melatonin 1 mg immediate release tablet Drug: Melatonin
swallowing 1 piece, collecting saliva afterwards
Other Names:
  • Melatonin 2,5 mg capsule (compounded by UMCU Pharnacy)
  • Melatonin 1 mg tablet Thiopharma
  • Sleepzz 0.1 mg oromucosal tablet

Active Comparator: melatonin 2,5mg immediate release capsule Drug: Melatonin
swallowing 1 piece, collecting saliva afterwards
Other Names:
  • Melatonin 2,5 mg capsule (compounded by UMCU Pharnacy)
  • Melatonin 1 mg tablet Thiopharma
  • Sleepzz 0.1 mg oromucosal tablet

Active Comparator: melatonin 0.1 mg oromucosal tablet Drug: Melatonin
swallowing 1 piece, collecting saliva afterwards
Other Names:
  • Melatonin 2,5 mg capsule (compounded by UMCU Pharnacy)
  • Melatonin 1 mg tablet Thiopharma
  • Sleepzz 0.1 mg oromucosal tablet




Primary Outcome Measures :
  1. Melatonin concentration (ng/ml) in saliva [ Time Frame: At 15 min, 30 min, 1 hour, 1.5 hour, 2 hours, 3 hours (tablet; capsule); at 25 minutes, 40 minutes, 60 minutes, 1.5 hour, 2 hours and 3 hours (sublingual tablet ) ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers (male) aged from 18 to 35 years old without insomnia.

Exclusion Criteria:

  • Lactose intolerance.
  • Hepatic disease
  • Kidney disease
  • Auto-immune disease
  • Depression
  • Neurological disorders
  • Oromucosal diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107079


Locations
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Netherlands
Pharmacy department of faculty of veterinary medicine Utrecht University
Utrecht, Netherlands
Sponsors and Collaborators
Utrecht University

Additional Information:
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Responsible Party: Ingeborg Marianne van Geijlswijk, hospital pharmacist, Utrecht University
ClinicalTrials.gov Identifier: NCT02107079    
Other Study ID Numbers: Melaform
2011-003068-61 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by Ingeborg Marianne van Geijlswijk, Utrecht University:
melatonin
bioavailability
pharmacokinetics
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants