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

Completed

• Conditions: Osteoporosis; porous bones; 10005959

• Registration Number: NL-OMON37168
• Lead Sponsor: Institut de Recherches Internationales Servier I.R.I.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>bioequivalence for vitamin D3 pharmacokinetic (PK) parameters between a single<br /><br>oral administration of a capsule of vitamin D3 1000 IU as concentrate with<br /><br>cyclodextrin and a single oral administration of a capsule of vitamin D3 1000<br /><br>IU as concentrate (i.e. cholecalciferol 25 µg) without cyclodextrin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To collect information on safety and tolerability of concentrate of vitamin D3<br /><br>with RAMEB and concentrate of vitamin D3 without cyclodextrin.</p><br>