A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers

A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers.

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.

Study Overview

• Status: Completed
• Conditions: Health, Subjective
• Intervention / Treatment: Drug: CTL0801 (Azilsartan); Drug: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin); Drug: CTL0802 (Rosuvastatin)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; CTL0801 (Azilsartan) QD, 4days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days	Drug: CTL0801 (Azilsartan); CTL0801 (Azilsartan), single dose, daily, repeated oral administration; Drug: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin); CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration
Experimental: Arm B; CTL0802 (Rosuvasatin) QD, 7days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days	Drug: CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin); CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration; Drug: CTL0802 (Rosuvastatin); CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): September 13, 2021

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Azilsartan medoxomil
• Other Study ID Numbers: CT-L08-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No