AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence study comparing two temazepam 20 mg tablet formulations after fasted administration; an open, randomized, single centre, single dose study with crossover design in healthy subjects

This study is looking at two different versions of a 20 mg temazepam tablet, a medication often used for short-term sleep difficulties. We want to check if both tablets deliver the same amount of the medicine into your bloodstream and at similar speeds. This helps make sure that different versions of the same drug will work in the same way. Healthy people aged 18 and older are invited to take part. It's a single-dose study, meaning you'll take the medicine once, and we'll compare the two tablets over several visits. This type of study is called a bioequivalence study, and it's an important step in making sure medicines are safe and effective.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Orion Corporation

Enrolment target

Start

05 May 2026

short-term treatment of insomnia

What is this study about?

This study is designed to compare two different versions of a medicine called temazepam. Temazepam is a drug commonly used for a short time to help people with insomnia, which is difficulty sleeping.

Think of it like this: if you buy two different brands of flour, you'd expect them to bake a cake in roughly the same way. In medicine, when a new generic version of an existing drug is made, we need to make sure it acts just like the original brand-name drug. This study is doing exactly that – checking if a new version of the 20 mg temazepam tablet works in the same way as another established version.

We'll be looking to see how much of the medicine gets into your blood and how quickly, after you've taken a single dose of each tablet. This helps doctors and pharmacists be confident that regardless of which approved temazepam tablet you take, you'll get the same effect in your body.

Key takeaways

This study compares two temazepam tablets for short-term sleep problems.
It checks if both tablets deliver the medicine equally effectively in healthy people.
Participants will be healthy adults, aged 18 or older.
You'll take one tablet, have blood tests, then repeat with the second tablet.
Your contribution helps ensure medicine quality and safety.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 years or older. We welcome both men and women.

Being 'healthy' usually means you don't have any significant ongoing illnesses or medical conditions, and you're not regularly taking other medications that could interfere with the study drug.

Specific details about health checks will be discussed with you by the study team to make sure you're a good fit for the study and that it's safe for you to participate.

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, without major ongoing medical conditions?
Are you comfortable with having blood samples taken?
Are you able to commit to several visits at the study clinic?
Are you willing to avoid certain foods or drinks before and during study visits as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic multiple times. During these visits, you'll be given one of the temazepam tablets. We'll then take several blood samples over a period of time to measure how the medicine moves through your body.

Because this is a 'crossover' study, you won't just take one type of tablet. At a later point, after the first medicine has completely left your system, you'll return to the clinic and take the other temazepam tablet, and we'll repeat the process of taking blood samples. This allows us to compare how each tablet works in the same person.

Between these visits, there will be a 'washout' period, which is a break to ensure the first dose of medicine is completely out of your body before you take the second. The total time you'll be involved in the study, from your first visit to your last, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health, as you are a healthy volunteer. However, you'll be contributing to important medical research that helps ensure medicines are safe and work as expected for future patients. Like all medicines, temazepam can have side effects, and these will be fully explained to you before you agree to take part. You will be closely monitored by medical staff during the study. You're completely free to change your mind and withdraw from the study at any time, for any reason, without it affecting your 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 temazepam used for?

Temazepam is a medicine usually prescribed for a short time to help people who are having trouble sleeping (insomnia).

Why are you comparing two tablets?

We want to check if two different versions of the 20 mg temazepam tablet work in the same way in the body. This is important to ensure all approved versions of a medicine are equally effective.

Will I have to stay at the clinic?

The study design involves taking a single dose of the medicine and then having blood samples taken over a period. The study team will explain the exact schedule and whether any overnight stays are needed.

Will I get paid for taking part?

Information about any payment for your time and expenses will be provided by the study team if you express interest in joining.

What if I feel unwell during the study?

You will be carefully looked after by medical staff throughout the study. If you feel unwell at any point, you should tell the study team immediately.