A PHASE I, OPEN-LABEL, FIXED-SEQUENCE, THREE-PERIOD CROSSOVER TRIAL TO EVALUATE THE PHARMACOKINETICS OF TWO DIFFERENT TABLET FORMULATIONS OF BCI 952 COMPARED TO THE OVER-ENCAPSULATED BCI-952 PRODUCT COMPONENTS IN HEALTHY MALE SUBJECTS

A PHASE I, OPEN-LABEL, FIXED-SEQUENCE, THREE-PERIOD CROSSOVER TRIAL TO EVALUATE THE PHARMACOKINETICS OF TWO DIFFERENT TABLET FORMULATIONS OF BCI 952 COMPARED TO THE OVER-ENCAPSULATED BCI-952 PRODUCT COMPONENTS IN HEALTHY MALE SUBJECTS - BCI-952 three-period crossover bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36120

Enrollment

Registered

2011-03-15

Start date

2011-04-14

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

depression

Interventions

Treatments Period 1: a single dose of BCI-952 consisting of an over-encapsulated commercially available buspirone IR 15 mg tablet and an over-encapsulated commercially available melatonin SR 3 mg ca

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteer Age : 18 * 40 years, inclusive Body mass index (BMI) : 18-30 kg/m2, inclusive non-smoking or smoking less then or equal to 5 cigarettes/day

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 the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Safety Tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)