Day 1 - 6 40mg omeprazole QD; on Day 5 a single-dose of SOF/VEL with 250 mL of Coca Cola Classic is administered (test 1).

Day 8 - 13: 40mg omeprazole QD; on Day 12 a single-dose of SOF/VEL is administered (test 2).

Day 15 - 21: no treatment with omeprazole; on Day 19 a single-dose of SOF/VEL is administered (reference).

Hepatitis C

Swallowing Disorder

velpatasvir

Radboud university medical Center

Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.

Influence of the Acidic Beverage Cola on the Absorption of the HCV Agent Velpatasvir in Healthy Volunteers Being Treated With the Proton Pump Inhibitor Omeprazole.

Determination of velpatasvir AUC0-inf by noncompartmental analysis.
Descriptive statistics for the plasma concentrations of velpatasvir at each sampling time. Descriptive statistics for each PK parameter per treatment (geometric mean + CV%).
Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of A (Test 1) vs. C (Reference) and of B (Test 2) vs. C (Reference).
AUC0-inf geometric mean ratios with a 90% Cl falling entirely within the range of 0.7 to 1.43 are considered bioequivalent.

To evaluate the safety and tolerability of SOFA/EL tablets in healthy volunteers.
Adverse events after administration of SOFA/EL in the three interventions will be described and compared (including clinically relevant laboratory abnormalities).

Determination of velpatasvir Cmax by noncompartmental analysis.

Determination of velpatasvir AUC0-48h by noncompartmental analysis.

Radboud University

An open-label, 3-period, single-centre, phase-I, multi PPI dose, single velpatasvir dose trial in 12 healthy volunteers.

Thalassemia

CN128

placebo

The first affiliated hospital, Zhejiang University

Clinical Study of CN128 in Thalassemia Patients

A First in Human, Randomized, Double-blind, Single Ascending Dose, Phase Ia Clinical Study to Assess the Safety, Tolerability and Pharmacokinetic Parameters of CN128 Tablets in Thalassemia Patients Aged 16 and Above

Vital signs checks; determine the patient's pulse which is one kind of physiological parameter

Vital signs checks; determine the patient's respiration which is one kind of physiological parameter

Vital signs checks; both systolic and diastolic will be measured

Laboratory test: WBC, RBC, NEUT, BASO, etc.

Laboratory test: colour, appearance, glucose, protein, ketone, bilirubin, leukocyte, blood, and microscopic

Laboratory test: ALT, AST, ALP, LDH, AMS, BUN, ALB, etc.

Laboratory test: fibrinogen, prothrombin time and corresponding INR, APTT

Pharmacokinetics parameters: mean residence time

Hangzhou Zede Pharma-Tech Co., Ltd.

paliperidone ER 1 tablet of 500 mg once daily on Day 1 and Day 15

divalproex sodium ER 2 tablets of 500 mg once daily from Days 5 through 18

Schizophrenia

Epilepsy

1 tablet of 500 mg once daily on Day 1 and Day 15

paliperidone ER

2 tablets of 500 mg once daily from Days 5 through 18

divalproex sodium ER

An Open-Label, Drug-Drug Interaction Study between Steady-State Valproic Acid and Single-Dose Paliperidone Extended-Release in Healthy Men

A Drug Interaction Study of Valproic Acid and Single-dose Paliperidone Extended-Release (ER) in Healthy Men

An Open-Label, Drug-Drug Interaction Study Between Steady-State Valproic Acid and Single-Dose Paliperidone Extended-Release in Healthy Men

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

CN128 Tablets

Short-term Clinical Study of CN128 in Thalassemia Patients

Phase Ib Clinical Study to Assess the Safety, Tolerability and Pharmacokinetic Parameters of CN128 Tablets to Administration in Thalassemia Patients Aged 16 and Above

The patient's height will be determined, and it's one kind of Physical examination.

The patient's weight will be determined, and it's one kind of Physical examination.

The patient's skin, neck, eyes, ears, nose, throat, chest, back, lymph nodes, arms, legs, nervous system, etc. will be observed, and it's one kind of Physical examination.

The patient's pulse will be determined, and it's one kind of vital signs checks.

The patient's respiration will be determined, and it's one kind of vital signs checks.

Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.

The patient's temperature will be determined, and it's one kind of vital signs checks.

The patient's electrocardiogram will be measured, and it's one kind of laboratory test.

The patient's blood examination（WBC (Unit: 10E9/L), RBC (Unit: 10E9/L), NEUT (Unit: 10E9/L), BASO (Unit: 10E9/L), etc.）will be determined at Day 3, Day 7, Day 11 respectively, and it's one kind of laboratory test.

The patient's blood biochemical examination（ALT (Unit: U/L), AST (Unit: U/L), etc.）will be determined at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The patient's blood coagulation function ( fibrinogen (Unit: g/L), prothrombin time (Unit: s), APTT (Unit: s) , etc.) will be determined at Day 11, and it's one kind of laboratory test.

The patient's serum iron will be determined at Day 11, and it's one kind of laboratory test.

The colour of urine will be observed at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The appearance of urine will be observed at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The glucose of urine will be determined at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The protein of urine will be determined at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

It's the number of subjects with adverse events after administration.

cola/hepatitis

Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.

Clinical Study of CN128 in Thalassemia Patients

A Drug Interaction Study of Valproic Acid and Single-dose Paliperidone Extended-Release (ER) in Healthy Men

Short-term Clinical Study of CN128 in Thalassemia Patients

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