NCT05002244

Brief Summary

This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

1 month

First QC Date

July 30, 2021

Last Update Submit

December 21, 2021

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (2)

  • AUCτ,ss

    predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

  • Cmax,ss

    predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

Secondary Outcomes (2)

  • Tmax,ss

    predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

  • Cmin,ss

    predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose

Study Arms (2)

Arm A

EXPERIMENTAL

CTL0801 (Azilsartan) QD, 4days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days

Drug: CTL0801 (Azilsartan)Drug: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)

Arm B

EXPERIMENTAL

CTL0802 (Rosuvasatin) QD, 7days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days

Drug: CTL0802 (Rosuvastatin)Drug: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)

Interventions

CTL0801 (Azilsartan)DRUG

CTL0801 (Azilsartan), single dose, daily, repeated oral administration

Arm A
CTL0802 (Rosuvastatin)DRUG

CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration

Arm B
CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)DRUG

CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration

Arm AArm B

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A subject who weighs 50 kg or more (45 kg or more for women)
  • A subject who does not have clinically significant congenital or chronic diseases
  • A subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator
  • A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of the investigational drug
  • A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, the characteristics of the investigational drugs, and expected adverse reactions

You may not qualify if:

  • A subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them
  • A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
  • A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc)
  • A subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration
  • A subject who is judged ineligible for participation in this study by the principal investigator
  • A female volunteer who is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

azilsartanRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 12, 2021

Study Start

July 23, 2021

Primary Completion

August 29, 2021

Study Completion

September 13, 2021

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations

KR(1)