HealthyPhase 1NCT07551713
Bioequivalence Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects
A Phase 1 study testing Tested Lidocaine and Prilocaine Cream and Reference Lidocaine and Prilocaine Cream (EMLA®) in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (EMLA®, AstraZeneca) were applied to healthy adult subjects under fasting conditions to evaluate the bioequivalence and safety of the two formulations Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tested Lidocaine and Prilocaine Cream and Reference Lidocaine and Prilocaine Cream (EMLA®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2020to 28 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 18 years or older (inclusive), both male and female.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 19.0-26.0 kg/m² (inclusive).
- Subjects who voluntarily sign the informed consent form, fully understand the study content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements.
- Normal, intact skin on the bilateral anterior thighs without damage.
- Able to maintain good communication with the investigator and comply with all clinical trial requirements.
- Subjects are generally in good health, or based on the investigator's clinical judgment and comprehensive consideration of the drug's characteristics, it is determined that the subject's medical history does not preclude participation in this clinical study.
Who cannot join
- Smokers or alcohol drinkers (consuming more than 14 units of alcohol per week within 1 month prior to enrollment: 1 unit = 285 mL of beer with approximately 3.5% alcohol, or 25 mL of spirits with approximately 40% alcohol, or 100 mL of wine with approximately 10% alcohol; smoking an average of ≥ 5 cigarettes per day within 3 months prior to the first dose) and/or inability to abstain from smoking and alcohol during the trial period; or a positive alcohol breath test.
- Use of any prescription drug (e.g., antihypertensives), any over-the-counter drug, vitamin, herbal supplement, or drug that alters liver enzyme activity within 4 weeks prior to the first dose, or use of products affecting metabolism such as grapefruit or grapefruit-containing products within 2 weeks prior to the first dose; or refusal to refrain from consuming products containing alcohol, chocolate, caffeine, poppy seeds, or xanthine-rich products from 24 hours prior to the first dose until the end of the trial.
- Significant changes in dietary habits (e.g., dieting, binge eating) or strenuous exercise within 2 weeks prior to the first dose.
- Special dietary requirements that prevent adherence to the unified diet.
- Use of any drug with a long half-life that may affect this study, or participation as a subject in any drug or medical device clinical trial within 3 months prior to the first dose.
- Blood donation or blood loss ≥ 400 mL within 3 months prior to the first dose.
Show all 18Show fewer
- History of food or drug allergy, or allergic constitution.
- Any clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), posteroanterior chest X-ray, or clinical laboratory test results at screening.
- History or presence of chronic or serious diseases of the hematologic, circulatory, digestive, urinary, respiratory, nervous, immune, or endocrine systems; mental abnormalities; metabolic disorders; or any other condition that may affect the study results.
- Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPPA).
- History of drug abuse or drug dependence.
- Birthmarks, scars, tattoos, or open wounds at the administration site (bilateral anterior thighs).
- History of allergy to amide local anesthetics or any excipient of the investigational drug.
- History of methemoglobinemia or atopic dermatitis.
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency (i.e., favism).
- History of needle phobia, blood phobia, or intolerance to venipuncture, or known severe bleeding tendency.
- Pregnant or lactating women; female subjects who had unprotected sexual intercourse within 2 weeks prior to screening; female subjects with a positive pregnancy test; subjects (or their partners) planning for fertility or sperm/egg donation during the entire trial period and within 3 months after the last dose; unwillingness to use one or more contraceptive measures during the trial and within 3 months after the last dose.
- Poor compliance or subjects deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence and Safety Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects : A Randomized, Open-label, Single-dose, Two-period, Cross-over Study
The test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (EMLA®, AstraZeneca) were applied to healthy adult subjects under fasting conditions to evaluate the bioequivalence and safety of the two formulations
- Conditions
- Healthy
- Being tested
- Tested Lidocaine and Prilocaine Cream, Reference Lidocaine and Prilocaine Cream (EMLA®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested Lidocaine and Prilocaine CreamDrug
Under fasting conditions, 15 g of the test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes.
Reference Lidocaine and Prilocaine Cream (EMLA®)Drug
Under fasting conditions, 15 g of the reference formulation (EMLA®, AstraZeneca.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Test formulation | Experimental | Lidocaine and Prilocaine Cream (5 g/tube, with each gram containing 25 mg lidocaine and 25 mg prilocaine) Manufacturer: Haisco Pharmaceutical Group Co., Ltd. Receives: Drug: Tested Lidocaine and Prilocaine Cream |
| Reference formulation | Experimental | Lidocaine and Prilocaine Cream (5 g/tube, with each gram containing 25 mg lidocaine and 25 mg prilocaine) Manufacturer: AstraZeneca. Receives: Drug: Reference Lidocaine and Prilocaine Cream (EMLA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum blood concentration, the pharmacokinetic parameters of lidocaine and prilocaine in plasma
Measured: From the start of administration to 36 hours post-dose
AUC(0-t)
The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of lidocaine and prilocaine in plasma
Measured: From the start of administration to 36 hours post-dose
AUC(0-∞)
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of lidocaine and prilocaine in plasma
Measured: From the start of administration to 36 hours post-dose
Secondary outcomes (1)
AEs
The incidence and severity of adverse events (AEs)
Measured: From the time of signing ICF to the end of follow-up，up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start11 Jun 2020
- Primary completion10 Jul 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551713
- Sponsor's protocol ID
- HSK-160-BE-01
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence and Safety Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects : A Randomized, Open-label, Single-dose, Two-period, Cross-over Study
- ClinicalTrials.gov ID
- NCT07551713
- Acronym / sponsor ID
- HSK-160-BE-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 27 Apr 2026 (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.
The test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (EMLA®, AstraZeneca) were applied to healthy adult subjects under fasting conditions to evaluate the bioequivalence and safety of the two formulations
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test formulation | Experimental | Drug: Tested Lidocaine and Prilocaine CreamLidocaine and Prilocaine Cream (5 g/tube, with each gram containing 25 mg lidocaine and 25 mg prilocaine) Manufacturer: Haisco Pharmaceutical Group Co., Ltd. |
| Reference formulation | Experimental | Drug: Reference Lidocaine and Prilocaine Cream (EMLA®)Lidocaine and Prilocaine Cream (5 g/tube, with each gram containing 25 mg lidocaine and 25 mg prilocaine) Manufacturer: AstraZeneca. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects aged 18 years or older (inclusive), both male and female.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 19.0-26.0 kg/m² (inclusive).
- Subjects who voluntarily sign the informed consent form, fully understand the study content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements.
- Normal, intact skin on the bilateral anterior thighs without damage.
- Able to maintain good communication with the investigator and comply with all clinical trial requirements.
Key exclusion criteria (18 listed)
- Smokers or alcohol drinkers (consuming more than 14 units of alcohol per week within 1 month prior to enrollment: 1 unit = 285 mL of beer with approximately 3.5% alcohol, or 25 mL of spirits with approximately 40% alcohol, or 100 mL of wine with approximately 10% alcohol; smoking an average of ≥ 5 cigarettes per day within 3 months prior to the first dose) and/or inability to abstain from smoking and alcohol during the trial period; or a positive alcohol breath test.
- Use of any prescription drug (e.g., antihypertensives), any over-the-counter drug, vitamin, herbal supplement, or drug that alters liver enzyme activity within 4 weeks prior to the first dose, or use of products affecting metabolism such as grapefruit or grapefruit-containing products within 2 weeks prior to the first dose; or refusal to refrain from consuming products containing alcohol, chocolate, caffeine, poppy seeds, or xanthine-rich products from 24 hours prior to the first dose until the end of the trial.
- Significant changes in dietary habits (e.g., dieting, binge eating) or strenuous exercise within 2 weeks prior to the first dose.
- Special dietary requirements that prevent adherence to the unified diet.
- Use of any drug with a long half-life that may affect this study, or participation as a subject in any drug or medical device clinical trial within 3 months prior to the first dose.
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 |
|---|---|---|
| Tested Lidocaine and Prilocaine CreamUnder fasting conditions, 15 g of the test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes. | Drug | Test formulation |
| Reference Lidocaine and Prilocaine Cream (EMLA®)Under fasting conditions, 15 g of the reference formulation (EMLA®, AstraZeneca.) was applied to the anterior thigh of the subjects (over an area of 10 cm × 10 cm, totaling 100 cm2), with the administration completed within 5 minutes. | Drug | Reference formulation |
Primary outcome
Cmax
Time frame: From the start of administration to 36 hours post-dose
The maximum blood concentration, the pharmacokinetic parameters of lidocaine and prilocaine in plasma
AUC(0-t)
Time frame: From the start of administration to 36 hours post-dose
The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of lidocaine and prilocaine in plasma
AUC(0-∞)
Time frame: From the start of administration to 36 hours post-dose
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of lidocaine and prilocaine in plasma
1 secondary outcome
AEs
Time frame: From the time of signing ICF to the end of follow-up，up to 10 days
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 Apr 2026.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tested Lidocaine and Prilocaine Cream and Reference Lidocaine and Prilocaine Cream (EMLA®) in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
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 18 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 Apr 2026. 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 China. 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?
Cmax (time frame: From the start of administration to 36 hours post-dose). The study lists 3 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 Apr 2026.