Bioequivalence study comparing a fixed-dose combination of clopidogrel and enteric aspirin versus the simultaneous administration of separate formulations in healthy Korean male subjects

An open-label, randomized, 2-treatment, 3-period, 3-sequence crossover bioequivalence study comparing a tablet containing clopidogrel and enteric aspirin versus the simultaneous administration of separate formulations of these two drugs in healthy Korean male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001205

Enrollment

150

Registered

2014-08-25

Start date

2014-07-16

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Oral Route under fasting conditions 75mg of clopidogrel and 100mg of enteric ASA, single dose in each period

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Korean male subjects, between 19 and 55 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. Certified as healthy by a comprehensive clinical assessment. Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria

Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV 1 and anti-HIV2 Ab), syphilis RPR antibodies. Positive result on urine drug screen (amphetamines/methamphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). Positive alcohol breath test. Any contraindication to clopidogrel or ASA.

Design outcomes

Primary

Measure	Time frame
Assessment of PK parameter - area under the curve over the time (AUC) from time zero to the time of last quantifiable concentration (AUClast) for clopidogrel and ASA;Assessment of PK parameter - maximum concentration (Cmax) for clopidogrel and ASA	—

Secondary

Measure	Time frame
Assessment of PK parameter - terminal half-life (t1/2z) for clopidogrel and ASA;Number of subjects with adverse events;Assessment of PK parameter - time to reach Cmax (tmax) for clopidogrel and ASA;Assessment of PK parameter - AUC for clopidogrel and ASA	—

Countries

Korea, Republic of

Contacts

Public ContactSun Kyung Jung

Chungnam National University Hospital

Outcome results