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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.
The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.
The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| marine collagen peptide production process I | Experimental | standardized to 10 g provided as single dose. Orally applied in water. |
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| marine collagen peptide production process II | Experimental | standardized to 10 g provided as single dose. Orally applied in water. |
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| marine collagen peptide fish source I | Experimental | standardized to 10 g provided as single dose. Orally applied in water. |
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| marine collagen peptide fish source II | Experimental | standardized to 10 g provided as single dose. Orally applied in water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Peptides | Dietary Supplement | Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. | Pharmakokinetic variable | pre dose and up to 6 hours post dose |
| Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides. | Pharmakokinetic variable | pre dose and up to 6 hours post dose |
| Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides. | Pharmakokinetic variable | pre dose and up to 6 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides | Pharmakokinetic variables | pre dose and up to 6 hours post dose |
| Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoletta Virgilio, PhD | RousselotBVBA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
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double-blind
Pharmakokinetic variables |
| pre dose and up to 6 hours post dose |
| Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides | Pharmakokinetic variables | pre dose and up to 6 hours post dose |