AN OPEN-LABEL, STUDY WITH THREE PROPORTIONATE SIZES OF HPS-328 PATCH APPLIED FOR 168 HOURS AND ONE ORAL DOSE REGIMEN OF 5 MG BISOPROLOL FUMARATE ONCE DAILY FOR ONE WEEK, TO INVESTIGATE THE PHARMACOKINETICS, TOLERABILITY AND SAFETY OF HPS-328 PATCHES IN HEALTHY MALE SUBJECTS

AN OPEN-LABEL, STUDY WITH THREE PROPORTIONATE SIZES OF HPS-328 PATCH APPLIED FOR 168 HOURS AND ONE ORAL DOSE REGIMEN OF 5 MG BISOPROLOL FUMARATE ONCE DAILY FOR ONE WEEK, TO INVESTIGATE THE PHARMACOKINETICS, TOLERABILITY AND SAFETY OF HPS-328 PATCHES IN HEALTHY MALE SUBJECTS - HPS-328 transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36691

Enrollment

Registered

2011-01-11

Start date

2011-01-26

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

hoge bloeddruk hypertensia

Interventions

Active compound: bisoprolol in transdermal patch (HPS-328, 90 mg bisoprolol per 15 cm2) or bisopolol fumarate as tablets, 5 mg per tablet (Emcor®).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age 40 - 65 year - BMI 18.0 - 29.9 - caucasian

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, 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 or in case of donating more than 1 liter of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
- Pharmacokinetics - Safety - ambulatory blood Pressure Recordings and pulse	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)