Ended Human Pharmacology (Phase I)- Bioequivalence Study No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the prophylaxis and symptomatic therapy of nausea and vomiting of various etiologies, especially kinetosis.

An open label, randomized, four-period, four-sequence single dose, crossover trial in healthy volunteers to determine the relative bioavailability of Dimenhydrinate 50 mg (Test) administered with and without water vs. Vomex A 50 mg Lösung zum Einnehmen im Beutel (Reference 1) and Biodramina 50 mg Comprimidos (Reference 2)

EU CTIS ID: 2022-502420-51-00

What this study is testing

To assess the bioequivalence of an oral test preparation containing 50 mg dimenhydrinate per sachet Dimenhydrinate 50 mg Coated Granules when administered without water (Test 1 IMP) and Dimenhydrinate 50 mg Coated Granules when administered with 200 mL water (Test 2 IMP) as compared to two market standards Vomex A 50 mg Lösung zum Einnehmen im Beutel (Reference 1 IMP) and Biodramina 50 mg Comprimidos (Reference 2 IMP) under fasting conditions in four different periods, at least 7 days apart.

Human Pharmacology (Phase I)- Bioequivalence Study

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

[1] Male or female subject
[2] Age between 18 and 55 years (inclusive the date of signing informed consent)
[3] Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who: (i) has reached natural menopause (defined as at least 12 months of spontaneous amenorrhea); (ii) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa)
[4] Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent until the end of the trial
[5] Physically and mentally healthy as judged by means of medical and standard laboratory examinations
[6] Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year) and non-users of other nicotine containing products, confirmed by urine cotinine test

You likely can't join if

[1] Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous trial)
[10] Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity)
[11] Any history of drug hypersensitivity especially to the active and inactive ingredients of the dimenhydrinate preparations)
[12] Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
[13] Clinically significant illness within 4 weeks before screening visit
[14] Major surgery of the gastrointestinal tract except for appendectomy

See the full eligibility criteria

Who can join

[1] Male or female subject
[2] Age between 18 and 55 years (inclusive the date of signing informed consent)
[3] Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who: (i) has reached natural menopause (defined as at least 12 months of spontaneous amenorrhea); (ii) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa)
[4] Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent until the end of the trial
[5] Physically and mentally healthy as judged by means of medical and standard laboratory examinations
[6] Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year) and non-users of other nicotine containing products, confirmed by urine cotinine test
[7] BMI within the range (including the borders) of 18.5 to 30.0 kg/m2
[8] Informed consent given in written form according to chapter 5.3 of clinical trial protocol.

What rules you out

[1] Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous trial)
[10] Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity)
[11] Any history of drug hypersensitivity especially to the active and inactive ingredients of the dimenhydrinate preparations)
[12] Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
[13] Clinically significant illness within 4 weeks before screening visit
[14] Major surgery of the gastrointestinal tract except for appendectomy
[15] Any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
[16] History of difficulty in swallowing
[17] Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
[18] Administration of depot injectable solutions or medications with a half-life > 1 week (including trial medications) within 6 months before screening visit
[19] Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before screening visit
[2] Randomization into the present trial more than once
[20] Intake or administration of any systemic or topical medication (including OTC medication and especially intake of antacids e.g. aluminum hydroxide, magnesium hydroxide, and simethicone or herbal medication e.g. St. John's wort, kava kava) within 2 weeks before screening visit
[21] Vaccination within 14 days prior to screening visit
[22] Medication with drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within 60 days before screening visit
[23] Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg
[24] Pulse rate outside the range of 50 to 90 beats/min
[25] Axillary body temperature outside the interval of 35.5 to 37.1°C
[26] Any clinically significant abnormality of the resting ECG (12-lead)
[27] Laboratory values outside normal range with clinical relevance
[28] Special diet due to any reason, e.g. vegetarians
[29] History or presence of piercings in the mouth (e.g. tongue) or wearing braces or dentures
[3] Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
[30] Subjects who are known or suspected: - not to comply with the trial directives; - not to be reliable or trustworthy; - not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed; - to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in; - subject is in custody or submitted to an institution due to a judicial order.
[4] History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months before screening visit or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year before screening visit
[5] Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
[6] Regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
[7] Positive drug screening
[8] Positive alcohol test
[9] Pregnant and/or nursing women. Positive pregnancy test

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.