Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

Alcon

Status and phase: Completed; Phase 4

Conditions: Vision

Treatments: Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength); Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength); Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057966

SMA-09-32

Details and patient eligibility

About

This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 35
2. Body Mass Index (BMI) 21-27 kg/m2
3. Must be able to give written informed consent
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion criteria

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

ICAPS AREDS Softgel Capsule - Full Strength

Experimental group

Description:

ICAPS Eye Vitamin and Mineral Supplement - Softgel

Treatment:

Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)

ICAPS AREDS Softgel Capsule - Half Strength

Experimental group

Description:

ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)

Treatment:

Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)

ICAPS AREDS coated tablets - Full Strength

Experimental group

Description:

ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets

Treatment:

Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)