Bioequivalence clinical trial of two formulations of rosuvastatin/ezetimibe.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Normon S.A.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

25 Nov 2022 → 27 Jan 2023

Decision date (initial)

2022-11-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence

To evaluate the relative bioavailability of the test formulation of rosuvastatin/ezetimibe compared to the commercial formulation taken as reference and to demonstrate their bioequivalence according to health authorities’ criteria.

Secondary objectives 1

1. Tolerability of the formulations will be evaluated.

Conditions and MedDRA coding

Healthy volunteers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Aged from 18 to 55.
3. No clinically significant organic or psychic conditions.
4. No clinically significant abnormalities in medical records and physical examination.
5. No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis (see Appendix C).
6. No clinically significant abnormalities in vital signs and electrocardiogram.

Exclusion criteria 12

1. 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%)].
2. 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.
3. Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
4. History of sensitivity to any drug.
5. Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
6. Smoker.
7. Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
8. Having donated blood in the last month before start of the study.
9. Pregnant or breastfeeding women. Child-bearing age women participating in the study will compromise to use a high effective contraceptive method (see Appendix D) or will be abstinent during their participation in the study.
10. 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).
11. Inability to follow the instructions or collaborate during the study.
12. History of difficulty in swallowing.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Rosuvastatine AUC0-t and Cmax.
2. Total ezetimibe: AUC0-72 and Cmax.

Secondary endpoints 2

1. Rosuvastatine: AUC0-∞, Tmax and residual area.
2. Total Ezetimibe: Tmax.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Normon S.A.

Sponsor organisation

Laboratorios Normon S.A.

Address

Ronda De Valdecarrizo 6

City

Tres Cantos

Postcode

28760

Country

Spain

Scientific contact point

Organisation

Laboratorios Normon S.A.

Contact name

Carlos Govantes (R&D Director)

Public contact point

Organisation

Laboratorios Normon S.A.

Contact name

Carlos Govantes (R&D Director)

Third parties 4

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications