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To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

JW Pharmaceutical logo

JW Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Treatment D
Drug: Treatment C
Drug: Treatment E
Drug: Treatment A
Drug: Treatment B

Study type

Interventional

Funder types

Industry

Identifiers

NCT05463497
JW21101

Details and patient eligibility

About

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Full description

  1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
  2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Enrollment

40 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Subjects does not meet the Inclusion Criteria

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 4 patient groups

Group 1(N=10)
Other group
Description:
Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
Treatment:
Drug: Treatment B
Drug: Treatment A
Drug: Treatment C
Group 2(N=10)
Other group
Description:
Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
Treatment:
Drug: Treatment B
Drug: Treatment A
Drug: Treatment C
Group 3(N=10)
Other group
Description:
Treatment A for Period I Treatment E Treatment D \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
Treatment:
Drug: Treatment D
Drug: Treatment A
Drug: Treatment E
Group 4(N=10)
Other group
Description:
Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
Treatment:
Drug: Treatment D
Drug: Treatment A
Drug: Treatment E

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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