Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers

Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers - ADASUVE® QT/QTc Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38911

Enrollment

Registered

2013-04-22

Start date

2013-05-03

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

Agitatie commotion fash

Interventions

All subjects will be exposed to 3 different treatments. A Inhalator: 10 mg ADASUVE, twice daily + Oral: Placebo, once daily B Inhalator: Placebo, twice daily + Oral: Placebo, once daily C Inhalator: P

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male or female (females with child bearing potential have to use an effective method of contraception) - between 18 and 65 years of age, inclusive - BMI between 18 and 32 kg/m2, inclusive - no smoking during at least 30 days prior to the screening

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: Plasma concentrations, pharmacokinetic parameters Safety: Adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)