NCT02385071View on ClinicalTrials.gov

A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 28, 2015

Primary Completion Date

September 9, 2015

Study Completion Date

September 9, 2015

Conditions
Healthy
Interventions
DRUG

Treatment A

150 milligram (mg) SMV capsule with water under fed conditions.

DRUG

Treatment B

Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.

DRUG

Treatment C

Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).

DRUG

Treatment D

\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.

DRUG

Treatment E

3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.

DRUG

Treatment F

3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.

Trial Locations (1)

Unknown

Harrow

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT02385071 - A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants | Biotech Hunter | Biotech Hunter