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

Not Applicable

• Registration Number: CTRI/2024/03/063457
• Lead Sponsor: atural Alternatives International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified