Randomized, open-label, single dose, four-period, cross-over drug-drug interaction study comparing reference products Crestor 20 mg film coated tablets, Norvasc 10 mg tablets and Tritace 10 mg tablets administrated concomitantly versus each drug administrated alone in healthy male and female subjects under fasting conditions.

2023-505153-41-00 Human pharmacology (Phase I) - Other Ended

Start 17 Aug 2023 · End 5 Dec 2023 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 60
Countries 1
Sites 1

Not applicable (submitted trial is a study in healthy subjects).

Key facts

Sponsor
Adamed Pharma S.A.
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
17 Aug 2023 → 5 Dec 2023
Decision date (initial)
2023-07-04
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Not applicable (submitted trial is a study in healthy subjects).

VersionLevelCodeTermSystem organ class
20.0 PT 10020772 Hypertension 100000004866

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Adamed Pharma S.A.

14 Total trials 2 Recruiting 11 Ended
Commercial
Sponsor organisation
Adamed Pharma S.A.
Address
Ul Mariana Adamkiewicza 6a
City
Czosnow
Postcode
05-152
Country
Poland

Scientific contact point

Organisation
Adamed Pharma S.A.
Contact name
Pharmacokinetic Study Team

Public contact point

Organisation
Adamed Pharma S.A.
Contact name
Pharmacokinetic Study Team

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Ended 60 1
Rest of world — 0 —

Investigational sites

Czechia

1 site · Ended
Quinta-Analytica s.r.o.
Clinical Unit, Prazska 1486/18c, Hostivar, Prague

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Czechia 2023-08-17 2023-12-05 2023-09-04 2023-09-26

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-05-25 Czechia Acceptable
2023-07-04
 2023-07-04
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-07-10 Czechia Acceptable
2023-07-04
 2023-07-10
3 NON SUBSTANTIAL MODIFICATION NSM-2 2023-07-17 Czechia Acceptable
2023-07-04
 2023-07-17

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