Bioequivalence between LAZ696 200/10 mg and the free combination of sacubitril valsartan 200 mg tablet and amlodipine 10 mg tablet and food effect in Japanese healthy participants

A phase I , open-label, single-dose, randomized, three-period crossover study to investigate the bioequivalence between LAZ696 200/10 mg and the free combination of sacubitril valsartan 200 mg tablet and amlodipine 10 mg tablet, and the effect of food on the pharmacokinetics and safety of LAZ696 200/10 mg in Japanese healthy participants - CLAZ696B11101

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250102

Enrollment

Registered

2025-05-15

Start date

2025-06-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health participants

Interventions

Single oral dose of LAZ696 200/10 mg x 1(fasted) Single oral dose of LAZ696 200/10 mg x 1 (fed) Single oral combined dose of sacubitril valsartan 200 mg tablet x 1 and amlodipine 10 mg tablet x 1(fast

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed informed consent must be obtained prior to participation in the study. Japanese male and female 18 to 55 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG, and laboratory tests at screening and initial baseline. Participants must weigh at least 50.0 kg to participate in the study and must have a Body Mass Index (BMI) within the range of 18.0-30.0 kg/m2 at screening.

Exclusion criteria

Exclusion criteria: Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. Significant illness that has not resolved within two weeks prior to first dosing. Smokers (use of tobacco/nicotine products within 3 months of first dosing). Urine cotinine levels will be measured during screening and initial baseline for all participants. Smokers will be defined as any participant who reports tobacco use or who has a urine cotinine above the cutoff defined by the local laboratory.

Design outcomes

Primary

Measure	Time frame
PK parameters: Cmax, AUClast, AUCinf	—

Contacts

Public ContactSatoru Sinmyo

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026