Bioequivalence study for vitamin D3 pharmacokinetic parameters following single oral administrations of vitamin D3 1000 IU with cyclodextrin and vitamin D3 1000 IU without cyclodextrin in Caucasian healthy volunteers

Bioequivalence study for vitamin D3 pharmacokinetic parameters following single oral administrations of vitamin D3 1000 IU with cyclodextrin and vitamin D3 1000 IU without cyclodextrin in Caucasian healthy volunteers - Vitamin D3 bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37168

Enrollment

Registered

2013-01-10

Start date

2013-01-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis porous bones

Interventions

1 single dose of Vitamin D3 with cyclodextrine on Day 1 or 8 and 1 single dose of Vitamin D3 without cyclodextrine on Day 1 or 8

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female subjects 18-65 yrs, inclusive BMI: 18.5-30 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
bioequivalence for vitamin D3 pharmacokinetic (PK) parameters between a single oral administration of a capsule of vitamin D3 1000 IU as concentrate with cyclodextrin and a single oral administration of a capsule of vitamin D3 1000 IU as concentrate (i.e. cholecalciferol 25 µg) without cyclodextrin	—

Secondary

Measure	Time frame
To collect information on safety and tolerability of concentrate of vitamin D3 with RAMEB and concentrate of vitamin D3 without cyclodextrin.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)