Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Randomized, open-label, replicated single-dose, 4-period, 2-sequence crossover study to assess the comparative bioavailability of test product Amlodipine/Valsartan/Hydrochlorothiazide 10 mg/160 mg/12.5 mg film-coated tablets to reference product Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets in healthy male and female subjects under fasting conditions.

This research is looking at a type of medication used to treat high blood pressure. It compares a new combined tablet (Amlodipine/Valsartan/Hydrochlorothiazide) with an existing one (Exforge HCT) to see if they deliver the same amount of medicine to the body at the same speed. This is called a 'bioequivalence' study. Healthy adult volunteers, both men and women, took the medicines on an empty stomach. The study aimed to ensure that the new tablet is just as effective and safe as the existing one, even though they might be made by different companies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Pharma Start LLC

Enrolment target

Start

28 Aug 2025

not applicable (submitted trial is bioavailability)

What is this study about?

Imagine you have a headache and take a painkiller. You want to know that the medicine you're taking, no matter which brand, will work in your body in a similar way to relieve your pain. This study is similar, but for a combined medication used to lower high blood pressure.

Researchers are comparing two different versions of a tablet that contains three medicines: Amlodipine, Valsartan, and Hydrochlorothiazide. These three ingredients work together to help manage blood pressure. One version is an existing medicine called Exforge HCT, and the other is a new ‘test’ version. The main goal is to check if these two tablets release the same amount of medicine into your bloodstream and at the same rate when taken on an empty stomach.

This kind of study, called a 'bioequivalence' study, is really important. It helps ensure that if a new version of a medication becomes available, patients can trust that it will work just as well as the original. It means doctors can confidently prescribe either version knowing that your body will absorb and use the medication effectively.

Key takeaways

This study compares two blood pressure medications.
It checks if a new version works the same as an existing one.
Healthy adults are taking part.
The aim is to ensure medicines are equally effective and safe.
Participants take both medications at different times.
Blood tests measure medicine levels in the body.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 or over. This study is open to both men and women.

Because this study is looking at how medicines are absorbed, participants need to be generally healthy and not have any serious ongoing medical conditions that might affect how their body handles the medicine.

Specific details about other health conditions, medications you might be taking, or lifestyle choices that could prevent you from taking part would be discussed with you by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally healthy?
Are you able to attend several study visits?
Are you comfortable having regular blood tests?
Do you understand you will receive medication on an empty stomach?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive both the new test medication and the existing medication at different times during the study. You would take these medicines on an empty stomach. The study is designed in a 'crossover' way, which means you would take one medicine during one period, and the other medicine during a different period. Your health would be checked regularly through blood tests to measure how much of the medication is in your system over several hours after you take it. You would also have regular check-ups with the study doctors. The study runs over four different periods, with breaks in between. The total duration of your involvement, including all visits and follow-ups, would be explained in full by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this type of study, a potential benefit is contributing to medical knowledge that helps ensure safe and effective medicines are available for everyone. As the medicines are already approved for use, severe unexpected risks are less likely, but there are always potential side effects from taking medication, which would be fully explained. You would also have blood samples taken. You are free to withdraw from the study at any time without giving a reason, and this would not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is 'bioequivalence'?

It means comparing two medicines to see if they deliver the same amount of active ingredient to your body at the same speed, so they should work in the same way.

Why is this study only for healthy people?

To clearly see how the medicines are absorbed in a typical person, without other health conditions affecting the results.

Will I get the new medicine or the old one?

You will get both, but at different times during the study, so researchers can compare them fairly in the same person.

Will I take these medicines long-term?

No, this study involves single doses over a short period to see how they are absorbed, not long-term treatment.

Is this a new medicine that's never been used before?

No, these are different versions of medications that are already approved and widely used for high blood pressure. This study compares how similar they are.