A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants
Recruiting
Phase 1
Interventional Study
Healthy Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 30 (estimated)
- Sponsor
- Abbisko Therapeutics Co, Ltd · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011 Capsules. A total of 15 healthy participants are planned to be enrolled. Participants will be randomized to Sequence A, Sequence B or Sequence C at a 1:1:1 ratio and rece…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Healthy subjects aged 18 to 45 years (inclusive) at screening;
2. Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
3. Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as…
Contacts