An open-label, individual study groups, fixed sequence, four-period crossover study comparing three proportionate sizes of HP 3020 patch applied for 24 hours with intravenous palonosetron injection (ALOXI®) and a one-period study with one size of HP-3020 patch applied for 168 hours, to investigate the pharmacokinetics, tolerability and safety of HP-3020 patches in healthy male subjects

An open-label, individual study groups, fixed sequence, four-period crossover study comparing three proportionate sizes of HP 3020 patch applied for 24 hours with intravenous palonosetron injection (ALOXI®) and a one-period study with one size of HP-3020 patch applied for 168 hours, to investigate the pharmacokinetics, tolerability and safety of HP-3020 patches in healthy male subjects - HP-3020 transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34113

Enrollment

Registered

2010-09-03

Start date

2010-09-21

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

chemotherapy induced nausea chemotherapy induced vomiting

Interventions

Study madication: palonosetron in transdermal patch (HP-3020, 0.6 mg palonosetron HCl per 6 cm2) and solution for intravenous injection (Aloxi®, 0.25 mg).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age 18- 55 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	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)