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One pill to rule two? combo drug tested in healthy men

NCT ID NCT01764178

Knowledge-focused Sponsor: JW Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested whether a single pill containing two medicines (pitavastatin for cholesterol and valsartan for blood pressure) works the same in the body as taking the two pills separately. Fifty-two healthy men took both versions in random order. The study only measured drug levels in the blood, not actual treatment effects or long-term safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pitavastatin and Valsartan (combined in one pill vs. separate pills)
What this could lead to
If the combination pill works as well as separate pills, it could simplify daily dosing for people with high cholesterol and high blood pressure.
What could go wrong
This is a very early, small study in healthy men only. It only checks how the drug moves through the body, not whether it actually treats disease or is safe long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

52 people

The number who actually took part.

Started

Jan 2013

Finished

Dec 2013

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy male volunteers * Age 20-55 years at the time of Screening * BMI 19-26 kg/m2 at the time of Screening Exclusion Criteria: * Received other investigational drug within 90 days prior to the first dose of study drug

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Conditions

The condition(s) this trial relates to.

hyperlipidemia hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemia Hypertension

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 138-736, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.