Pain, PostoperativePhase 1NCT05588557
A Phase I Study to Evaluate the Safety and PK of ND-340 in Healthy Volunteers
A Phase 1 study testing Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection and ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension in people with Pain, Postoperative, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial summary
This study focuses on ND-340 extended release injection suspension for healthy volunteers with a one-time nerve blockade to determine the safety, tolerability, and pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection and ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2022to 19 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 - 45 year-old healthy male subjects or female subjects who are in non-lactating and non-pregnant status.
- Subjects must have a Body Mass Index (BMI) of 18.5 to 30.0 Kg/m², inclusive. For male subjects, body weight must be above 50 kg; for female subjects, body weight must be above 45 kg. BMI = Weight (kg)/Height (m2).
- Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit.
- Able and willing to comply with all study visits and procedures.
- The informed consent form has been read, signed and dated by the subject.
- Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting subject-reported outcomes.
Who cannot join
- Subject has a sitting pulse rate outside the reference range of 50 to 90 beats per minute or an ear temperature outside the reference range of 35.0 to 37.5°C or a sitting blood pressure less than 90/50 mmHg or more than 140/90 mmHg at screening visit.
- Subject has clinically significant results of physical examination, laboratory tests, electrocardiogram, or chest X-ray as judged by the investigator at the screening visit.
- With abnormal results of sensory and neurological assessment as judged by the investigator at the screening visit.
- Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkalinephosphatase (ALP), or total bilirubin, if any one of them is out of the reference range.
- Presence of impaired renal function as indicated by abnormal creatinine or blood urea nitrogen values or abnormal urinary constituents, if any one of them is out of the reference range.
- Known of active infection with HIV, HBV, or HCV as defined by blood tests at the screening visit.
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- Presence of clinically significant illness, such as cardiovascular disease, cerebrovascular disease, metabolic disease, respiratory disease, neurological disease, psychiatric disease, cancers or immunological disease, may increase the risk of study as judged by the investigator at the screening visit.
- Subject does not agree not to take any prescription, over-the-counter medication, herbal medicine and dietary supplement (including multivitamins) within two weeks before hospital admission and until the end of the study.
- Subject does not agree not to consume any beverage or food that might affect the drug metabolism, such as pomelo, grapefruit or related products within one week before hospital admission and until the end of the study.
- Subject does not agree not to consume any caffeine-containing product (e.g., tea, coffee, coke, or chocolate) 3 days prior to hospital admission and until the end of the study.
- Subject does not agree not to consume any product containing tobacco, nicotine (such as e-cigarettes, nicotine gum), and alcohol 3 days prior to hospital admission and until the end of the study.
- Administration of an investigational drug within 2 months or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration; or planned administration of another investigational product or procedure during the study period.
- Donation or loss of more than 500 mL and 250 mL of blood within 3 months and 2 months before the screening visit, respectively.
- Known with a history of allergy or hypersensitivity to medicine as judged by the investigator at the screening visit.
- Female subject who is breast-feeding, pregnant, or planning to become pregnant.
- Subject does not agree to use effective non-hormonal contraception method to prevent from pregnancy ('double barrier method': condoms used concomitantly with vaginal sponge, diaphragm or intra-uterine contraceptive device) or abstain from sexual behavior with his/her partner from screening until the end of the study.
- Individual is not eligible to be a subject for other reasons based on the judgment of investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-escalation Study, Randomized Comparison with Active Control to Evaluate the Safety and Pharmacokinetics of a Single Administration of ND-340 Via Adductor Canal Block (ACB) and IPACK Block in Healthy Volunteers
This study focuses on ND-340 extended release injection suspension for healthy volunteers with a one-time nerve blockade to determine the safety, tolerability, and pharmacokinetic profile.
Read the detailed description
The current investigational product, ND-340, is a bupivacaine microsphere injection with an extended release profiling. Lipid microsphere, or liposphere, has been proposed as new type of lipid-based encapsulation system for drug delivery of bioactive compounds especially lipophilic compound.
ND-340 has not been studied in human before. However, MARCAINE® and EXPAREL® are both FDA-approved drugs, which contain the same active pharmaceutical ingredient (API) as ND-340, which is bupivacaine. MARCAINE® is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
In this study, Investigators will focus on determining the safety, tolerability, and pharmacokinetic profile of ND-340.
- Conditions
- Pain, Postoperative
- Being tested
- Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection, ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension
- Keywords
- Bupivacaine, Pharmacokinetics, Analgesics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine® 100mg/20mL (0.5%) bupivacaine solution for InjectionDrug
Subjects in this arm will receive a single administration of Marcaine® at the 150 mg.
Marcaine® will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee).
ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspensionDrug
Subjects in this arm will receive a single administration of ND-340 at the specified dose (90-320 mg).
ND-340 will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee).
| Study group | Role | What they receive |
|---|---|---|
| Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection | Active comparator | Marcaine® at 150 mg in each cohort. Receives: Drug: Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection |
| ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension | Experimental | ND-340(90-320 mg) at dose escalations Receives: Drug: ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as assessed by CTCAE v 5.0
Treatment-related adverse events will be analyzed by cohort
Measured: From administration of ND-340 to 140 hours
Changes in 12-lead ECG and Holter monitor
To definition safety profile in cardiac events, vent. rate, PR interval, QRS duration, QT interval, QTc interval
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
Changes in Laboratory test - hematology
Hemoglobin, Hct, RBC count, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelet count
Measured: Pre-dose, 140 hour
Changes in Laboratory tests - biochemistry
Albumin, Total protein, ALT, AST, ALP, Total bilirubin, BUN, Serum creatinine, K, Na, Mg, Ca, P, Uric acid, Total cholesterol, HbA1c
Measured: Pre-dose, 140 hour
Changes in Laboratory tests - urinalysis
pH, Specific gravity, Leukocyte, Erythrocyte, Protein, Glucose
Measured: Pre-dose, 140 hour
Changes in vital signs
To definition safety profile including body temperature,blood pressure, respiratory rate, pulse rate
Measured: Screening visit, day 0 (Pre-dose, 60 mins), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Changes in physical examination
To definition safety profile including general appearance, HEENT, neck, Lymph nodes, skin, cardiovascular, pulmonary, abdomen, neurological system, musculoskeletal/joints
Measured: Screening visit, day -1, Day 6
The tolerability and maximal tolerated dose (MTD) of ND-340 by dose-limiting toxicities (DLTs)
The incidence of DLT will be summarized by each cohort. The number of subject who has DLT will be summarized by cohorts.
and the determination of MTD in this study will be provided.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
Cmax
Maximum Plasma Concentration of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Tmax
Time of peak concentration of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
AUC 0-t
Area under the plasma concentration versus time curve from zero to t of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
AUC 0-∞
Area under the plasma concentration versus time curve from zero to infinity of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
T1/2
Terminal half life of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
CL/F
Clearance/Bioavailability of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
λz
Terminal elimination rate constant
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Vz/F
Apparent volume of distribution during terminal phase after non-intravenous administration
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
MRT 0-∞
Mean residence time from zero to infinity of ND-340
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Secondary outcomes (2)
Range of motion of knee
The range of motion (ROM) of knee as measured by knee flexion and extension at baseline and subsequent visits, and the change from baseline will be summarized descriptively by cohorts and drugs(ND-340 or Marcaine®).
Measured: Pre-dose, 1, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
The ambulation distance
The ambulation distance as measured by six-minute walk test (6MWT) at baseline and subsequent visits, and the change from baseline will be summarized descriptively by cohorts and drugs (ND-340 or Marcaine®).
Measured: Once a day on Pre-dose, Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start8 Jul 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects of each cohort will be randomly arranged to receive ND-340 or control drug (Marcaine® Injection 0.5%, equal to bupivacaine base 5 mg/mL) in the ratio of 3:1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chih-Peng Lin, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588557
- Sponsor's protocol ID
- NKC340-202101
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation Study, Randomized Comparison with Active Control to Evaluate the Safety and Pharmacokinetics of a Single Administration of ND-340 Via Adductor Canal Block (ACB) and IPACK Block in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05588557
- Acronym / sponsor ID
- NKC340-202101
- Conditions
- Pain, Postoperative
- Keywords
- Bupivacaine, Pharmacokinetics, Analgesics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on ND-340 extended release injection suspension for healthy volunteers with a one-time nerve blockade to determine the safety, tolerability, and pharmacokinetic profile.
Detailed description
The current investigational product, ND-340, is a bupivacaine microsphere injection with an extended release profiling. Lipid microsphere, or liposphere, has been proposed as new type of lipid-based encapsulation system for drug delivery of bioactive compounds especially lipophilic compound.
ND-340 has not been studied in human before. However, MARCAINE® and EXPAREL® are both FDA-approved drugs, which contain the same active pharmaceutical ingredient (API) as ND-340, which is bupivacaine. MARCAINE® is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
In this study, Investigators will focus on determining the safety, tolerability, and pharmacokinetic profile of ND-340.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The subjects of each cohort will be randomly arranged to receive ND-340 or control drug (Marcaine® Injection 0.5%, equal to bupivacaine base 5 mg/mL) in the ratio of 3:1.
| Arm | Type | Receives |
|---|---|---|
| Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection | Active comparator | Drug: Marcaine® 100mg/20mL (0.5%) bupivacaine solution for InjectionMarcaine® at 150 mg in each cohort. |
| ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension | Experimental | Drug: ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspensionND-340(90-320 mg) at dose escalations |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 20 - 45 year-old healthy male subjects or female subjects who are in non-lactating and non-pregnant status.
- Subjects must have a Body Mass Index (BMI) of 18.5 to 30.0 Kg/m², inclusive. For male subjects, body weight must be above 50 kg; for female subjects, body weight must be above 45 kg. BMI = Weight (kg)/Height (m2).
- Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit.
- Able and willing to comply with all study visits and procedures.
- The informed consent form has been read, signed and dated by the subject.
Key exclusion criteria (17 listed)
- Subject has a sitting pulse rate outside the reference range of 50 to 90 beats per minute or an ear temperature outside the reference range of 35.0 to 37.5°C or a sitting blood pressure less than 90/50 mmHg or more than 140/90 mmHg at screening visit.
- Subject has clinically significant results of physical examination, laboratory tests, electrocardiogram, or chest X-ray as judged by the investigator at the screening visit.
- With abnormal results of sensory and neurological assessment as judged by the investigator at the screening visit.
- Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkalinephosphatase (ALP), or total bilirubin, if any one of them is out of the reference range.
- Presence of impaired renal function as indicated by abnormal creatinine or blood urea nitrogen values or abnormal urinary constituents, if any one of them is out of the reference range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marcaine® 100mg/20mL (0.5%) bupivacaine solution for InjectionSubjects in this arm will receive a single administration of Marcaine® at the 150 mg. Marcaine® will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). | Drug | Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection |
| ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspensionSubjects in this arm will receive a single administration of ND-340 at the specified dose (90-320 mg). ND-340 will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). | Drug | ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension |
Primary outcome
Adverse events as assessed by CTCAE v 5.0
Time frame: From administration of ND-340 to 140 hours
Treatment-related adverse events will be analyzed by cohort
Changes in 12-lead ECG and Holter monitor
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
To definition safety profile in cardiac events, vent. rate, PR interval, QRS duration, QT interval, QTc interval
Changes in Laboratory test - hematology
Time frame: Pre-dose, 140 hour
Hemoglobin, Hct, RBC count, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelet count
Changes in Laboratory tests - biochemistry
Time frame: Pre-dose, 140 hour
Albumin, Total protein, ALT, AST, ALP, Total bilirubin, BUN, Serum creatinine, K, Na, Mg, Ca, P, Uric acid, Total cholesterol, HbA1c
Changes in Laboratory tests - urinalysis
Time frame: Pre-dose, 140 hour
pH, Specific gravity, Leukocyte, Erythrocyte, Protein, Glucose
Changes in vital signs
Time frame: Screening visit, day 0 (Pre-dose, 60 mins), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
To definition safety profile including body temperature,blood pressure, respiratory rate, pulse rate
Changes in physical examination
Time frame: Screening visit, day -1, Day 6
To definition safety profile including general appearance, HEENT, neck, Lymph nodes, skin, cardiovascular, pulmonary, abdomen, neurological system, musculoskeletal/joints
The tolerability and maximal tolerated dose (MTD) of ND-340 by dose-limiting toxicities (DLTs)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
The incidence of DLT will be summarized by each cohort. The number of subject who has DLT will be summarized by cohorts. and the determination of MTD in this study will be provided.
Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Maximum Plasma Concentration of ND-340
Tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Time of peak concentration of ND-340
AUC 0-t
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Area under the plasma concentration versus time curve from zero to t of ND-340
AUC 0-∞
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Area under the plasma concentration versus time curve from zero to infinity of ND-340
T1/2
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Terminal half life of ND-340
CL/F
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Clearance/Bioavailability of ND-340
λz
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Terminal elimination rate constant
Vz/F
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Apparent volume of distribution during terminal phase after non-intravenous administration
MRT 0-∞
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Mean residence time from zero to infinity of ND-340
2 secondary outcomes
Range of motion of knee
Time frame: Pre-dose, 1, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
The ambulation distance
Time frame: Once a day on Pre-dose, Day 1 and Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Peng Lin, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection and ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension in people with Pain, Postoperative, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events as assessed by CTCAE v 5.0 (time frame: From administration of ND-340 to 140 hours). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.