Comparison of two modified release (M.R.) formulations of S16257 22.5 mg o.d, with S 16257 immediate release tablet 7.5 mg b.i.d and linearity assessment of S 16257 pharmacokinetic over 7.5, 22.5 and 30 mg o.d doses of one of the M.R. formulations An open-label, phase I, single-centre, randomised five-way crossover study in healthy participants.

Comparison of two modified release (M.R.) formulations of S16257 22.5 mg o.d, with S 16257 immediate release tablet 7.5 mg b.i.d and linearity assessment of S 16257 pharmacokinetic over 7.5, 22.5 and 30 mg o.d doses of one of the M.R. formulations An open-label, phase I, single-centre, randomised five-way crossover study in healthy participants. - S 16257 comparative PK study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38936

Enrollment

Registered

2013-04-02

Start date

2013-05-02

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

Cardiovascular disease

Interventions

This study will consist of 5 different treatments divided over 5 periods. On Day 1 to Day 5 of Periods 1 to 3 the volunteers will receive once daily one Ivabradine MR tablet or one Ivabradine MR cap

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female Caucasian subjects, non-smoking or smoking less then 10 cigarettes per day, 18 - 65 yrs, inclusive, 18.5 - 30.0 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 90 days before the start of this study or being a blood donor within 3 months from the start of the study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: S 16257 plasma concentrations, pharmacokinetic parameters	—

Secondary

Measure	Time frame
Safety: Physical examination, vital signs, 12-lead ECG, laboratory tests (haematology, blood biochemistry and urinalysis), adverse events and concomitant treatments	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)