Bioavailability of 50 mg dimenhydrinate granules taken with or without water versus reference formulations for nausea and vomiting in healthy volunteers

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What is this study about?

The study focuses on a medication used to prevent and treat nausea and vomiting, especially the type caused by motion (kinetosis). The test product contains the active ingredient dimenhydrinate in a coated granule form, while two established medicines, Vomex A (a liquid solution) and Biodramina (tablet), serve as reference standards.

The purpose is to determine whether the test product has similar bioavailability—the amount of drug that reaches the bloodstream—as the reference medicines. Healthy volunteers receive a single dose of each product in a random order, with at least a week between doses. In some periods the test granules are taken with a small amount of water, in others without water, and all doses are given while the participants have not eaten (fasting). This design allows each participant to act as their own comparison, helping to show if the new form works the same as the existing treatments.

1 randomization and assignment to a dosing sequence

after enrollment, you will be randomly placed into one of four possible sequences. each sequence determines the order in which you will receive the four study medications during the trial.

2 first dosing period

you will arrive at the study site after at least ten hours of fasting (no food or drink except water).

the first medication assigned by your sequence will be given as a single dose. the dose is 50 mg of dimenhydrinate, provided in the form specified for that period:

– if the medication is the test preparation without water, you will swallow the coated granules directly with no water.

– if the medication is the test preparation with water, you will swallow the coated granules together with 200 mL of water.

– if the medication is the reference product Vomex A, you will ingest the oral solution containing 50 mg dimenhydrinate.

– if the medication is the reference product Biodramina, you will ingest one tablet containing 50 mg dimenhydrinate.

after taking the medication, you will remain at the site for a series of blood samples that are taken over several hours to measure how the drug is absorbed.

3 washout period before the next dose

at least seven days must pass before the next dosing period. during this time you may resume normal eating and drinking, but you must not take any other medication containing dimenhydrinate.

4 second dosing period

the same procedures as in step 2 are repeated, using the second medication assigned by your sequence. you will again fast for at least ten hours, receive a single dose of 50 mg dimenhydrinate in the specified form, and stay for blood sampling.

5 washout period before the third dose

another minimum seven‑day interval is required before the third dosing period.

6 third dosing period

you will repeat the fasting, dosing, and observation procedures with the third medication assigned by your sequence.

7 washout period before the fourth dose

a final minimum seven‑day interval separates the third and fourth dosing periods.

8 fourth dosing period

you will complete the trial by following the same steps—fasting, taking the last assigned 50 mg dimenhydrinate dose, and remaining for blood sampling.

9 final follow‑up

after the last blood sample, you will be asked to report any adverse effects that occurred during the study. no further medication will be taken.

Who Can Join the Study?

You must be a man or a woman who wants to join the study.
You need to be between 18 and 55 years old on the day you sign the consent form.
If you are a woman who cannot become pregnant, you may join. This includes women who have naturally stopped having periods for at least 12 months (menopause), women who had both ovaries removed at least 6 weeks ago (called bilateral oophorectomy), or women who have had a permanent fallopian‑tube surgery (tubal ligation).
If you are a woman who could become pregnant (reproductive potential), you must use a reliable birth‑control method (or agree to start one) from the time you sign the consent until the study ends.
You must be in good physical and mental health, as shown by a medical check‑up and standard lab tests.
You must be a non‑smoker or have stopped smoking at least 6 months ago, with a total smoking history of no more than 5 pack‑year equivalents (one pack‑year means smoking one pack per day for one year). You also must not use any other nicotine products, and this will be confirmed with a urine test.
Your Body Mass Index (BMI) – a number that compares your weight to your height – must be between 18.5 and 30.0, inclusive.
You must sign a written informed consent form agreeing to take part in the trial.

Who Cannot Join the Study?

Participation in another clinical trial at the same time or within the past 90 days.
Being enrolled in this study more than once.
Giving blood or losing more than 500 mL of blood (including plasma donation) within the past 90 days.
Having a history of drug or illegal drug use (marijuana within 6 months, cocaine, amphetamines, etc., within 1 year).
Drinking too much alcohol (more than 2 drinks per day or 10 drinks per week, or a history of alcoholism).
Consuming large amounts of caffeine‑containing drinks or foods (more than about 500 mg of caffeine per day, roughly 5 cups of coffee).
Having a positive drug test.
Having a positive alcohol test.
Being pregnant, possibly pregnant, or breastfeeding.
Having any significant allergy, such as asthma or other allergic diseases.
Being allergic to dimenhydrinate or any of its ingredients.
Having any important medical condition, such as heart, kidney, liver, lung, metabolic, hormone, blood, digestive, nerve, or mental health problems.
Being sick with a significant illness within the last 4 weeks.
Having had major stomach or intestinal surgery (except a simple appendix removal).
Having a chronic disease that could affect how the drug is absorbed, spread, broken down, or removed from the body.
Having difficulty swallowing.
Testing positive for HIV, hepatitis B, or hepatitis C infections.
Receiving long‑acting injectable medicines (half‑life longer than 1 week) within the last 6 months.
Taking medicines that affect enzymes, are toxic to organs, or stay in the body a long time, within the last 4 weeks.
Taking any regular medication (including over‑the‑counter drugs, antacids, or herbal products like St. John’s wort or kava) within the last 2 weeks.
Receiving a vaccination within the last 14 days.
Taking drugs that can change major body systems (such as barbiturates, phenothiazines, cimetidine, omeprazole) within the last 60 days.
Having a resting blood pressure outside 100‑140 mm Hg (systolic) or 60‑90 mm Hg (diastolic).
Having a resting pulse rate outside 50‑90 beats per minute.
Having an axillary (under‑arm) temperature outside 35.5‑37.1 °C.
Having a significant abnormality on a resting 12‑lead ECG (heart rhythm test).
Having laboratory test results that are outside the normal range and are clinically important.
Following a special diet (for example, vegetarian) that could affect the study.
Having mouth piercings, braces, or dentures.
Being judged unlikely to follow the study rules, to understand the information, or to give reliable consent, or being in a precarious financial or legal situation (such as custody).

Where you can join this trial?

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Site Name	City	Country	Status
Dhprhndkxy Cdpoosxdklwl Coolpa Ajcgijysr Oji	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	15.09.2023

Trial locations

Investigated Drugs:

DIMENHYDRINATE

Dimenhydrinate is the medication being tested in this study. It is a drug that helps prevent nausea, vomiting, and dizziness caused by motion sickness. In the trial, it is given as coated granules that the participants take by mouth, either with water or without water, to see how well it works compared to the standard products.

Vomex A is one of the reference medicines used for comparison. It is an oral solution that contains dimenhydrinate, the same active ingredient as the test product. Participants take this liquid form of the drug to provide a standard against which the new granule formulation can be measured.

Biodramina is the second reference medicine in the study. It comes as tablets that also contain dimenhydrinate. This tablet version serves as another standard comparison, helping researchers understand how the new granule form performs relative to an existing tablet product.

Motion sickness – Motion sickness occurs when the brain receives mismatched signals about movement from the inner ear, eyes, and other sensors. It usually starts with a sense of unease, quickly leading to nausea and may progress to vomiting if the motion continues. Symptoms often appear within minutes of traveling by car, boat, plane, or during virtual reality experiences. The intensity can increase with longer exposure or stronger sensory conflict. Some individuals develop anticipatory symptoms before travel. The condition typically subsides once the motion stops.

Trial ID:

2022-502420-51-00

Protocol code:

CHE21003

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Bioavailability of 50 mg dimenhydrinate granules taken with or without water versus reference formulations for nausea and vomiting in healthy volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?