BridgeMD
Randomized, open-label, single dose, two-period, cross-over bioequivalence study comparing test formulation Rosuvastatin/Amlodipine/Ramipril capsule, hard 10mg/5mg/5mg versus reference products Crestor 10 mg film coated tablets, Norvasc 5 mg tablets, Tritace 5 mg tablets in healthy male and female subjects under fasting conditions.
EU CTIS ID: 2023-503822-38-00
What this study is testing
To evaluate the pharmacokinetic properties and to compare the bioavailability of Test Product (T) versus Reference Products taken concurrently (R1 + R2 + R3) in healthy volunteers under fasting conditions.
- 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
- Healthy males and non-pregnant and non-breast-feeding females*, ≥18 and ≤ 60 years of age (on the day of Informed Consent Form signing). Caucasian race. *Pregnancy will be tested during screening and check-in procedure for each Period.
- Non-smoker or past smoker (who has stopped smoking at least 3 months before the first dosing).
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2, (on the day of screening).
- Subject is available for the whole study and has provided his/her written informed consent.
- Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (heart rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator.
- All laboratory screening results within the normal range or deemed clinically insignificant by Investigator.
You likely can't join if
- Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
- Use of systemic drugs known to alter hepatic metabolism within 90 days prior to the first dosing.
- Any systemic prescription treatment within 28 days before the first dosing, except hormonal contraceptives or substitution taken without significant changes in dose for 90 days prior to the first dosing.
- Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment (e.g. Saint John´s Wort) and/or food supplements within 14 days before the first dosing.
- Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
See the full eligibility criteria
Who can join
- Healthy males and non-pregnant and non-breast-feeding females*, ≥18 and ≤ 60 years of age (on the day of Informed Consent Form signing). Caucasian race. *Pregnancy will be tested during screening and check-in procedure for each Period.
- Non-smoker or past smoker (who has stopped smoking at least 3 months before the first dosing).
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2, (on the day of screening).
- Subject is available for the whole study and has provided his/her written informed consent.
- Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (heart rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator.
- All laboratory screening results within the normal range or deemed clinically insignificant by Investigator.
- Acceptance of use of contraceptive measures during the whole study by both female and male subjects*. *Methods of highly effective contraception for female subjects of childbearing potential: -combined (estrogen and progestogen containing) hormonal contraception, either oral, intravaginal or transdermal or progestogen-only hormonal contraception associated with inhibition of ovulation, either oral, injectable or implantable, or intrauterine hormone-releasing system or bilateral tubal occlusion or vasectomised (sterilised) partner (provided that it is a sole sexual partner of the subject and medical assessment of the surgical success has been provided to the partner) or intrauterine device (non-hormonal) since at least 30 days prior to the first dosing and use one of the barrier methods or abstinence from any sexual intercourse or hormonal intrauterine device or oral hormonal contraceptives or substitution if taken without significant changes in dose for 90 days before the first dosing and without change during the study. Highly effective contraception should be combined with use of barrier method with spermicide (condom, diaphragm). Recommended methods of contraception for male subjects - to not donate sperm from the first study drug administration to at least 30 after the last drug administration. If a female partner of male participant in the study is of childbearing potential, the couple needs to use the above described highly effective contraception methods. If a female partner of male participant in the study is pregnant, the recommended contraception method is that the male must use barrier method (condom). Premenarcheal women, women with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy and postmenopausal women are not considered of childbearing potential. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. These contraception precautions are required during the study course and for at least 30 days after the last dose of IMP.
- The subject speaks and understands Czech fluently.
What rules you out
- Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
- Use of systemic drugs known to alter hepatic metabolism within 90 days prior to the first dosing.
- Any systemic prescription treatment within 28 days before the first dosing, except hormonal contraceptives or substitution taken without significant changes in dose for 90 days prior to the first dosing.
- Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment (e.g. Saint John´s Wort) and/or food supplements within 14 days before the first dosing.
- Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
- Positive results of drugs of abuse in urine at screening and at check-in.
- Positive result of alcohol breath test at screening and at check-in.
- Positive result of urine cotinine test at screening.
- Body temperature is out of the range of 35.7-36.9 °C at screening and at check-in.
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 105-140 mmHg for systolic BP and/or 70-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
- Existing gastrointestinal diseases, renal or hepatic diseases and/or pathological findings, which might interfere with the drug’s safety, tolerability, absorption and/or pharmacokinetics.
- Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
- Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at screening.
- Positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
- Less than 45 days between exit procedure in previous study and the first dosing in this study.
- Liver disease with elevation of serum transaminases present or in history, level of ALT, AST or GGT ≥ 3 x ULN at the screening.
- Level of serum sodium or potassium out of normal range unless evaluated by Investigator as non-significant for inclusion in the study.
- Creatine kinase (CK) out of normal range unless evaluated by Investigator as non-significant for inclusion in the study.
- Impaired kidney function, clearance of creatinine (MDRD) < 1 mL/s.
- Current or history of skeletal muscles disorders (muscular toxicity, myopathy and rhabdomyolysis) or current skeletal muscles injuries, including a family history of hereditary muscular disorders.
- History of angioedema.
- History or presence of serious clinical illness that can impact the fate of drugs (their absorption and/or distribution and/or metabolism and/or elimination).
- Current or history of heart failure, hypertension, aortal or mitral valve stenosis or hypertrophic cardiomyopathy.
- History or presence of lactose intolerance, galactose intolerance or glucose-galactose malabsorption syndrome.
- Current or history of hypothyreosis.
- Subject was vaccinated against COVID-19 less than 14 days before the screening and/or subject plans to be vaccinated against COVID-19 during the study.
- Subject was hospitalized for COVID-19 related reasons.
- Positive PCR test for SARS-CoV-2 or positive antigen test, if required for safety reasons before hospitalization in the study.
- History or severe allergy or allergic reactions to the study drugs or related drugs (e.g. ACE, dihydropyridine derivates) or any of the excipients.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Serious mental disease and/or inability to cooperate with clinical team.
- Orthostatic hypotension in history or during the screening procedure.
- Drug, alcohol (≥ 40 g pure ethanol per day for men or ≥ 20 g pure ethanol per day for women), solvents or caffeine abuse.
- Use of organ-toxic drugs within 90 days before the first dosing (e.g. any drug with a well-defined potential for toxicity to a major organ or system such as chloramphenicol, which may cause bone marrow suppression).
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.
Explore other conditions
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.