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Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

A Randomized, Open-label, Single Dose, 3-sequence and 3-period Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01869985
Enrollment
30
Registered
2013-06-05
Start date
2013-08-31
Completion date
2014-01-31
Last updated
2014-03-11

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

Conditions

Healthy

Keywords

HCP1104, Eperisone Hydrochloride, Aceclofenac

Brief summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Detailed description

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Interventions

DRUGHCP1104 / Mulex Tab. and Airtal Tab.

HCP1104 / Eperisone plus Aceclofenac

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male volunteers, age between 20 and 45 * BMI of \>20kg/m2 and \<28kg/m2 subject * Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion criteria

* Use of any prescription medication within 14 days prior to Day 1 * Use of any medication within 7 days prior to Day 1 * Participation in another clinical study within 60 days prior to start of study drug administration

Design outcomes

Primary

MeasureTime frame
Area Under Curve(AUC) last0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026