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

Health, Subjective Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002244
• Other study ID #: CT-L08-101
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2021
• Est. completion date: September 13, 2021

Study information

• Verified date: December 2021
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 13, 2021
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Health, Subjective

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt,ss		predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose
Primary	Cmax,ss		predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose
Secondary	Tmax,ss		predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose
Secondary	Cmin,ss		predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose