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A single dose three-way crossover oral bioavailability study of ß-alanine capsules in comparison with conventional ß-alanine in healthy human volunteers in fasting conditions

A double blind, randomized, single dose, three treatment, three way crossover, oral bioavailability study of investigational product containing ß- analine in healthy, adult, human participants under fasting conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063457
Enrollment
12
Registered
2024-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

None listed

Interventions

Intervention1: ß-alanine complex (400 mg): one capsule to be taken with water per day (daily for 30 days) Control Intervention1: Reference Product I - Conventional ß-alanine (400 mg): one capsule to b

Sponsors

Natural Alternatives International
Lead Sponsor
Academy of Material Research
Collaborator
MOLECULES BIOLABS PRIVATE LIMITED
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Normal healthy adult male and female human subjects of age between 18-65 years with a body mass index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2 2.Subject agrees avoid ß-alanine containing medications and dietary supplements from screening until last visit. 3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 4.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in.

Exclusion criteria

Exclusion criteria: 1.Evidence of allergy or known hypersensitivity to ß-alanine or other related drugs or other related drugs. 2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. 3.Any major illness in the last three months or any significant ongoing chronic medical illness. 4.Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system. 5.History of alcohol addiction or abuse. 6.Malabsorption syndrome that affects ß-alanine metabolism.

Design outcomes

Primary

MeasureTime frame
To evaluate the oral bioavailability of investigational product (ß-alanine complex (400 mg)), reference product I (Conventional ß-alanine (400 mg)) and reference product II (Conventional ß-alanine (1200 mg)) in healthy, adult, Human participants under fasting conditionsTimepoint: day 1—

Secondary

MeasureTime frame
To monitor the adverse events and to ensure the safety of the subjects.Timepoint: da1, day30—

Countries

India

Contacts

Public ContactShalini Dayananda

Unitree Health Care Diagnostics

unitreeclinicalresearch@gmail.com9845270377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026