Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers

NCT04114461 | Completed Phase 1

• 1 other identifier: HL-TOF-101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum concentration

  0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour

• AUC

  Area under curve

  0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour

Secondary Outcomes (1)

• AE

  0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour

Study Arms (2)

HL-TOF tab. 5mg

EXPERIMENTAL

Tofacitinib freebase

Drug: HL-TOF tab. 5mg

Xeljanz tab. 5mg

ACTIVE COMPARATOR

Tofacitinib citrate (5mg as tofacitinib)

Drug: Xeljanz tab. 5mg

Interventions

HL-TOF tab. 5mg DRUG

HL-TOF

Also known as: Tofacitinib freebase

HL-TOF tab. 5mg

Xeljanz tab. 5mg DRUG

Xeljanz

Also known as: Tofacitinib citrate

Xeljanz tab. 5mg

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Years 19-60
• No pathological symptoms or findings
• Suitable for the criteria for examination
• ≤SBP≤139, 60≤DBP≤89
• Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
• Contraceptive during the study period
• Volunteer for the study and sign to ICF

You may not qualify if:

• Subject with medical history which affect on the absorption of drug
• Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC\< 500cells/mm3, ALC\<500cells/mm3, Hb\<8g/dL
• Subject with hypersensitivity reaction to HL-TOF and Xeljanz
• Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Subject who take a vaccination within 30 days
• Subject who take a medication such as barbiturates within 30 days
• Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
• Subject who take alcohol more than 21 cups per week
• Subject who smoke 20 cigarettes per day
• Subject who participate in any clinical investigation within 6 month prior to study medication dosing
• Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
• Subject with decision of non-participation through investigator's review

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

YANGJI Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

tofacitinib

Study Officials

• JAEWOO KIM

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2X2

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: November 6, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

KR (1)