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Completed

NCT Number: NCT05002244

A Drug-Drug Interaction Study 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.

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Key information

Conditions

Health, Subjective

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTL0801 (Azilsartan)

Drug

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

CTL0802 (Rosuvastatin)

Drug

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

CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)

Drug

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

Primary outcomes

  1. AUCτ,ss

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

  2. Cmax,ss

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

Secondary outcomes

  1. Tmax,ss

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

  2. Cmin,ss

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

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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