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Randomised, crossover bioequivalence clinical trial of apixaban 5 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions
EU CTIS ID: 2023-503557-35-00
What this study is testing
To evaluate the relative bioavailability of the test formulation of apixaban tablets compared to the commercial formulations taken as reference and to demonstrate their bioequivalence according to health authorities’ criteria.
- 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
- Male or female subjects who, after receiving information about the design, the objectives of the project, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written consent to participate in the study.
- Aged from 18 to 55.
- No clinically significant organic or psychic conditions.
- No clinically significant abnormalities in medical records and physical examination.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis
- No clinically significant abnormalities in vital signs and electrocardiogram.
You likely can't join if
- Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- Inability to follow the instructions or collaborate during the study.
- History of difficulty in swallowing.
- Lactose intolerance.
- Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
See the full eligibility criteria
Who can join
- Male or female subjects who, after receiving information about the design, the objectives of the project, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written consent to participate in the study.
- Aged from 18 to 55.
- No clinically significant organic or psychic conditions.
- No clinically significant abnormalities in medical records and physical examination.
- No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis
- No clinically significant abnormalities in vital signs and electrocardiogram.
What rules you out
- Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
- Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- Inability to follow the instructions or collaborate during the study.
- History of difficulty in swallowing.
- Lactose intolerance.
- Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
- Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- History of sensitivity to any drug.
- Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
- Smoker.
- Daily consumers of alcohol and/or acute alcohol poisoning in the last week
- Having donated blood in the last month before start of the study.
- Pregnant or breastfeeding women. Child-bearing age women participating in the study will compromise to use a high effective contraceptive method or will be abstinent during their participation in the study, according to the Appendix C of this protocol.
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.